CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S

Introducer, Catheter

CORDIS WEBSTER, INC.

The following data is part of a premarket notification filed by Cordis Webster, Inc. with the FDA for Cordis Webster Preface Braided Guiding Sheath & Perry Exchange Dilator, Model #'s 301-803a, 301-803p, 301-803m, 301-813s.

Pre-market Notification Details

• Device ID: K982740
• 510k Number: K982740
• Device Name: CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S
• Classification: Introducer, Catheter
• Applicant: CORDIS WEBSTER, INC. 4750 LITTLEJOHN ST. Baldwin Park, CA 91706
• Contact: Mary Adams
• Correspondent: Mary Adams; CORDIS WEBSTER, INC. 4750 LITTLEJOHN ST. Baldwin Park, CA 91706
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-08-06
• Decision Date: 1998-08-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10846835000061	K982740	000
10846835000054	K982740	000
10846835000047	K982740	000
10846835000030	K982740	000
10846835000023	K982740	000