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510(k) K883887

AXIOM ATRAUM WOUND DRAINS by Axiom, Inc. — Product Code GBS

K883887 is an FDA 510(k) premarket notification submitted by Axiom, Inc. for the device "AXIOM ATRAUM WOUND DRAINS". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code GBS (Catheter, Ventricular, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Axiom, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1989
Date Received
September 13, 1988
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 Axiom, Inc.

  • K842443 — AXIOM STABLE II TRIGLYCERIDES TEST (September 13, 1984)
  • K842442 — AXIOM STABLE II URIC ACID TEST (August 16, 1984)
  • K842441 — AXIOM STABLE II CHOLESTEROL TEST (July 25, 1984)

Other clearances for product code GBS

  • K912645 — ATRIUMS PDR THORACIC CATHETER (September 13, 1991)
  • 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