BARD 8FR., 40CC. SHEATHLESS INTRA-AORTIC BALLOON CATHETERS, BAR 7FR., 30CC. SHEATHLESS INTRA-AORTIC BALLOON CATHETERS

System, Balloon, Intra-aortic And Control

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard 8fr., 40cc. Sheathless Intra-aortic Balloon Catheters, Bar 7fr., 30cc. Sheathless Intra-aortic Balloon Catheters.

Pre-market Notification Details

• Device ID: K981660
• 510k Number: K981660
• Device Name: BARD 8FR., 40CC. SHEATHLESS INTRA-AORTIC BALLOON CATHETERS, BAR 7FR., 30CC. SHEATHLESS INTRA-AORTIC BALLOON CATHETERS
• Classification: System, Balloon, Intra-aortic And Control
• Applicant: C.R. BARD, INC. 25 COMPUTER DR. Haverhill, MA 01832
• Contact: Sandra Perreand
• Correspondent: Sandra Perreand; C.R. BARD, INC. 25 COMPUTER DR. Haverhill, MA 01832
• Product Code: DSP
• CFR Regulation Number: 870.3535 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-05-11
• Decision Date: 1998-10-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00801902136749	K981660	000
10801902161960	K981660	000
10801902161977	K981660	000
10801902161991	K981660	000
10801902145663	K981660	000
10801902144208	K981660	000
10801902145649	K981660	000
10801902145656	K981660	000
20801902145646	K981660	000
20801902145653	K981660	000
20801902145660	K981660	000
10801902142419	K981660	000
10801902142426	K981660	000
30801902011177	K981660	000
30801902011184	K981660	000
00801902136732	K981660	000
10801902162004	K981660	000