NEEDLE'S EYE SNARE

Catheter, Embolectomy

COOK PACEMAKER CORP.

The following data is part of a premarket notification filed by Cook Pacemaker Corp. with the FDA for Needle's Eye Snare.

Pre-market Notification Details

• Device ID: K961992
• 510k Number: K961992
• Device Name: NEEDLE'S EYE SNARE
• Classification: Catheter, Embolectomy
• Applicant: COOK PACEMAKER CORP. ROUTE 66 RIVER RD. P.O. BOX 529 Leechburg, PA 15656
• Contact: Neal E Fearnot
• Correspondent: Neal E Fearnot; COOK PACEMAKER CORP. ROUTE 66 RIVER RD. P.O. BOX 529 Leechburg, PA 15656
• Product Code: DXE
• CFR Regulation Number: 870.5150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-05-21
• Decision Date: 1996-12-27
• Summary: summary