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510(k) K912645

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

K912645 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "ATRIUMS PDR THORACIC CATHETER". The FDA issued a decision of Substantially Equivalent on September 13, 1991. The device falls under product code GBS (Catheter, Ventricular, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Atrium Medical Corp. has at least 10 other 510(k) clearances on record.

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

Other clearances by Atrium Medical Corp.

  • K130131 — EDRAIN CHEST DRAINAGE SYSTEM (February 28, 2013)
  • K122138 — ATRIUM FLIXENE IFG VASCULAR GRAFT (August 17, 2012)
  • K121070 — C-QUR RPM MESH (April 26, 2012)
  • K113112 — CLEARWAY RX NB CATHETER (November 17, 2011)
  • K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT (October 5, 2010)
  • K093431 — CLEARWAY OTW MODEL 85912 (April 20, 2010)
  • K100076 — ATRIUM C-QUR OVT MESH (January 26, 2010)
  • K090909 — C-QUR V -PATCH MESH (June 4, 2009)
  • K082748 — ATRIUM PROLITE S MESH (January 14, 2009)
  • 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)
  • K872457 — AN3500 WORTH DRAIN (July 21, 1987)
  • K872459 — AN3100 MULHOLLAND 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)

FDA data resources