VASCUTRAK PTA DILATATION CATHETER

Catheter, Percutaneous, Cutting/scoring

C. R. BARD, INC.

The following data is part of a premarket notification filed by C. R. Bard, Inc. with the FDA for Vascutrak Pta Dilatation Catheter.

Pre-market Notification Details

• Device ID: K103459
• 510k Number: K103459
• Device Name: VASCUTRAK PTA DILATATION CATHETER
• Classification: Catheter, Percutaneous, Cutting/scoring
• Applicant: C. R. BARD, INC. 1625 W 3RD STREET Tempe, AZ 85281
• Contact: Candace Wade
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: PNO
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2010-11-24
• Decision Date: 2010-12-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00801741061660	K103459	000
00801741061493	K103459	000
00801741061486	K103459	000
00801741061479	K103459	000
00801741061462	K103459	000
00801741061455	K103459	000
00801741061448	K103459	000
00801741061431	K103459	000
00801741061424	K103459	000
00801741061400	K103459	000
00801741061394	K103459	000
00801741061387	K103459	000
00801741061509	K103459	000
00801741061516	K103459	000
00801741061530	K103459	000
00801741061653	K103459	000
00801741061646	K103459	000
00801741061622	K103459	000
00801741061615	K103459	000
00801741061608	K103459	000
00801741061592	K103459	000
00801741061585	K103459	000
00801741061578	K103459	000
00801741061561	K103459	000
00801741061554	K103459	000
00801741061547	K103459	000
00801741061370	K103459	000
00801741061363	K103459	000
00801741061202	K103459	000
00801741061189	K103459	000
00801741061172	K103459	000
00801741061165	K103459	000
00801741061158	K103459	000
00801741061141	K103459	000
00801741061134	K103459	000
00801741061127	K103459	000
00801741061110	K103459	000
00801741061103	K103459	000
00801741061097	K103459	000
00801741061219	K103459	000
00801741061226	K103459	000
00801741061233	K103459	000
00801741061356	K103459	000
00801741061349	K103459	000
00801741061332	K103459	000
00801741061325	K103459	000
00801741061318	K103459	000
00801741061295	K103459	000
00801741061288	K103459	000
00801741061271	K103459	000
00801741061264	K103459	000
00801741061257	K103459	000
00801741061240	K103459	000
00801741061073	K103459	000
00801741061677	K103459	000
00801741062339	K103459	000
00801741062131	K103459	000
00801741062117	K103459	000
00801741062100	K103459	000
00801741062094	K103459	000
00801741062087	K103459	000
00801741062063	K103459	000
00801741062056	K103459	000
00801741062032	K103459	000
00801741062025	K103459	000
00801741062001	K103459	000
00801741061998	K103459	000
00801741062148	K103459	000
00801741062162	K103459	000
00801741062179	K103459	000
00801741062322	K103459	000
00801741062315	K103459	000
00801741062308	K103459	000
00801741062285	K103459	000
00801741062278	K103459	000
00801741062254	K103459	000
00801741062247	K103459	000
00801741062223	K103459	000
00801741062216	K103459	000
00801741062209	K103459	000
00801741062193	K103459	000
00801741061981	K103459	000
00801741061974	K103459	000
00801741061806	K103459	000
00801741061790	K103459	000
00801741061783	K103459	000
00801741061776	K103459	000
00801741061769	K103459	000
00801741061752	K103459	000
00801741061738	K103459	000
00801741061721	K103459	000
00801741061714	K103459	000
00801741061707	K103459	000
00801741061691	K103459	000
00801741061813	K103459	000
00801741061820	K103459	000
00801741061837	K103459	000
00801741061950	K103459	000
00801741061943	K103459	000
00801741061936	K103459	000
00801741061929	K103459	000
00801741061912	K103459	000
00801741061905	K103459	000
00801741061899	K103459	000
00801741061882	K103459	000
00801741061875	K103459	000
00801741061868	K103459	000
00801741061844	K103459	000
00801741061684	K103459	000