FDA 510(k), K912645, Premarket Notification and Other Submitted Information

510(K) Number: K912645
Device Name: ATRIUMS PDR THORACIC CATHETER
Manufacturer: ATRIUM MEDICAL CORP.
Device Classification Name: Catheter, Ventricular, General & Plastic Surgery
Regulation Number: 878.4200
Classification Product Code: GBS
Date Received: 06/17/1991
Decision Date: 09/13/1991
Regulation Medical Specialty: General & Plastic Surgery

Included in Original Request: The complete submitted and cleared K912645 510(k) premarket notification, along with the 510(k) Summary or Statement, if available, and any other information, included with that file, submitted to FDA CDRH for review.

NOTE: Originally 172 pages, but pages 90 - 172 were fully redacted and removed from the file.