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Europe, Middle East, Africa / Product Areas / Interventional Cardiology/Radiology / Peripheral Interventions / Passeo-35

Passeo^™35 PTA Balloon Catheter

Indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.^*

Product Highlights

Low profile and wide range of sizes

Features a low profile design for 5F and 6F sheath compatibility, a wide range of balloon diameters (3.0-10.0 mm) and lengths of up to 200 mm.¹

Puncture resistant

A robust balloon that provides effective dilation for more calcified lesions.¹

Enhanced crossability

The penta-fold balloon is fully coated when folded and only partly coated when inflated. This enables enhanced crossability while minimizing slippage during inflation of most calcified lesions. ¹

Balloon catheter
Catheter type	OTW
Recommended guide wire	0.035”
Tip	Soft, short, tapered, colored
Balloon material	SCP (Semi-Crystalline Polymer), controlled compliance
Balloon folding	5-fold
Balloon coating	Hydrophobic patchwork coating
Balloon markers	2 swaged markers
Sizes	ø 3.0 - 10.0 mm; L: 20 - 200 mm
Shaft	5F, hydrophobic coating, dual-lumen
Usable length	80, 90 and 130 cm
Guide wire lumen	Hydrophobic coating

		Balloon diameter x length (mm)
		ø 3.00 x 20-40	ø 3.00 x 60-200	ø 4.00 x 20-40	ø 4.00 x 60-200	ø 5.00 x 20-100	ø 5.00 x 120-200	ø 6.00 x 20-100	ø 6.00 x 120-200	ø 7.00 x 20-200	ø 7.00 x 120-200	ø 8.00 x 20-200	ø 9.00 x 20-80	ø 10.00 x 20-40^a	ø 10.00 x 20-80
Nominal Pressure (NP)	atm*	7	7	7	7	7	7	7	7	7	7	7	7	7	7
Nominal Pressure (NP)	ø (mm)	3	3	4	4	5	5	6	6	7	7	8	9	10	10
Rated Burst Pressure (RBP)	atm*	20	20	20	18	16	16	16	16	14	14	14	12	12	11
Rated Burst Pressure (RBP)	ø (mm)	3.5	3.2	4.5	4.32	5.7	5.3	6.7	6.4	7.7	7.3	8.7	9.4	10.5	10.3
^aUsable length:80cm; *1 atm= 1.013 bar

	Balloon ø (mm)	Catheter length 80 cm Balloon length (mm)
5F		20	40	60	80	100
	3	359545	359547	-	-	-
	4	359546	359548	-	-	-
	5	357282	357288	357294	357298	357302
	6	357283	357289	357295	357299	357303
	7	357284	357290	357296	357300	357304
6F	8	357285	357291	357297	357301	357305
	9	357286	357292	-	-	-
	10	357287	357293	-	-	-

	Balloon ø (mm)	Catheter length 90 cm Balloon length (mm)
5F		60	80	100	120	150	170	200
	3	383231	383235	383239	383243	389775	389776	387162
	4	383232	383236	383240	383244	383248	383252	383256
	5	-	-	-	383245	383249	383253	383257
	6	-	-	-	383246	383250	383254	383258
	7	-	-	-	383247	383251	383255	383259
6F	8	-	-	-	-	-	-	-
	9	383233	383237	-	-	-
	10	383234	383238	-	-	-	-	-

	Balloon ø (mm)	Catheter length 130 cm Balloon length (mm)
5F		20	40	60	80	100	120	150	170	200
	3	359549	359551	383264	383268	383272	383276	389777	389778	387163
	4	359550	359552	383265	383269	383273	383277	383281	383285	383289
	5	357306	357310	357314	357318	357322	383278	383282	383286	383290
	6	357307	357311	357315	357319	357323	383279	383283	383287	383291
	7	357308	357312	357316	357320	357324	383280	383284	383288	383292
6F	8	357309	357313	357317	357321	357325	-	-	-	-
	9	383260	383262	383266	383270	-	-	-	-	-
	10	383261	383263	383267	383267	-	-	-	-	-

IFU Link

Refer to this IFU link for a copy of the Instructions for Use and for a complete listing of the indications, contraindications, warnings and precautions.

References:

*Indication as per IFU. Australia: Not approved by Therapeutic Goods Administration for use within the renal and common iliac arteries.

Data on file.

Teleflex, the Teleflex logo, and Passeo are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S and/or other countries. All other names are the trademarks or registered trademarks of their respective owners. Refer to this IFU link for a copy of the Instructions for Use and for a complete listing of the indications, contraindications, warnings and precautions. Information in this material is not a substitute for the product Instructions for Use. Not all products may be available in all countries.
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