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510(k) K912645

ATRIUMS PDR THORACIC CATHETER by Atrium Medical Corp. — Product Code GBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1991
Date Received
June 17, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

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  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)

Other clearances for product code GBS

  • K883887 — AXIOM ATRAUM WOUND DRAINS (February 17, 1989)
  • K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESS (May 18, 1988)
  • K880895 — URESIL WOUND DRAIN TROCAR (March 14, 1988)
  • K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (February 16, 1988)
  • K873377 — CLOSED CHEST DRAINAGE SET W/SUTURES (October 28, 1987)
  • K872460 — AN3000 MAHONEY DRAIN (July 23, 1987)
  • K872459 — AN3100 MULHOLLAND DRAIN (July 21, 1987)
  • K872457 — AN3500 WORTH DRAIN (July 21, 1987)
  • K870015 — HCI ALL PURPOSE DRAIN/CATHETER SET (February 6, 1987)
  • K863560 — URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA (September 29, 1986)