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

Passeo^™-35 HP Balloon Catheter

Passeo^™-35 HP is a unique high pressure PTA Balloon to dilate most resistant lesions in complex anatomy.¹ It is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.^*

Product Highlights

96% success rate opening arteriovenous dialysis fistulae¹

Controlled compliance at high pressure¹

Minimizing vessel straightening¹

Balloon Catheter
Catheter Type	OTW
Recommended guide wire	0.035”
Tip	Soft, short, tapered
Balloon material	Nylon/Pebax, controlled compliance
Balloon folding	3-fold (ø 3.0 - 9.0 mm); 5-fold (ø 10.0 - 12.0 mm)
Balloon markers	2 radiopaque markers
Sizes	ø 3.0 - 12.0 mm; L: 20 - 100 mm
Shaft	5.9F, coaxial
Usable length	40 cm and 75 cm

		Balloon diameter x length (mm)
		ø 3.0 x 40	ø 4.0 x 20-40	ø 5.0 x 20-60	ø 6.0 x 20-100	ø 7.0 x 20-100	ø 8.0 x 20-80	ø 9.0 x 40	ø 10.0 x 40	ø 12.0 x 40
Nominal Pressure (NP)	atm**	14	14	14	14	14	14	12	12	12
Nominal Pressure (NP)	ø (mm)	3.11	4.01	5.01	6.05	6.93	7.98	8.96	10.02	11.86
Rated Burst Pressure (RBP)	atm**	27	27	27	25	23	22	20	20	18
Rated Burst Pressure (RBP)	ø (mm)	3.42	4.41	5.46	6.56	7.45	8.5	9.66	10.78	12.41
**1 atm= 1.013 bar

	Balloon ø (mm)	Catheter Length 75 cm Balloon length (mm)					Catheter Length 40 cm Balloon length (mm)
		20	40	60	80	100	40
6F	3	-	399077	-	-	-	-
	4	399078	399079	-	-	-	-
	5	399080	399081	399082	-	-	-
	6	399083	399084	399085	-	399086	399063
	7	399087	399088	399089	-	399090	399067
	8	399091	399092	399093	399094	-	399071
7F	9	-	399095	-	-	-	-
7F	10	-	399096	-	-	-	-
8F	12	-	399097	-	-	-	-

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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