VACCESS PTA DILATATION CATHETER

Catheter, Percutaneous

C.R. BARD, INC.

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

Pre-market Notification Details

• Device ID: K111850
• 510k Number: K111850
• Device Name: VACCESS PTA DILATATION CATHETER
• Classification: Catheter, Percutaneous
• Applicant: C.R. BARD, INC. 1625 WEST 3RD ST Tempe, AZ 85281
• Contact: Candace Wade
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: DQY
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2011-06-29
• Decision Date: 2011-07-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00801741059599	K111850	000
00801741059742	K111850	000
00801741059759	K111850	000
00801741059766	K111850	000
00801741059773	K111850	000
00801741059780	K111850	000
00801741059797	K111850	000
00801741059803	K111850	000
00801741059810	K111850	000
00801741059827	K111850	000
00801741059834	K111850	000
00801741059841	K111850	000
00801741059858	K111850	000
00801741059735	K111850	000
00801741059728	K111850	000
00801741059605	K111850	000
00801741059612	K111850	000
00801741059629	K111850	000
00801741059636	K111850	000
00801741059643	K111850	000
00801741059650	K111850	000
00801741059667	K111850	000
00801741059674	K111850	000
00801741059681	K111850	000
00801741059698	K111850	000
00801741059704	K111850	000
00801741059711	K111850	000
00801741059865	K111850	000
00801741059872	K111850	000
00801741060021	K111850	000
00801741060038	K111850	000
00801741121258	K111850	000
00801741121265	K111850	000
00801741121272	K111850	000
00801741121296	K111850	000
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00801741121319	K111850	000
00801741121326	K111850	000
00801741121333	K111850	000
00801741121340	K111850	000
00801741121357	K111850	000
00801741060014	K111850	000
00801741060007	K111850	000
00801741059889	K111850	000
00801741059896	K111850	000
00801741059902	K111850	000
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00801741059995	K111850	000
00801741121364	K111850	000