Home / 510(k) Clearances / K970857

510(k) K970857

ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO by Davis & Geck, Inc. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1997
Date Received
March 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Autotransfusion
Device Class
Class II
Regulation Number
868.5830
Review Panel
CV
Submission Type

Other clearances by Davis & Geck, Inc.

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  • K981582 — SURGILON, DERMALON, & OPHTHALON (July 13, 1998)
  • K980610 — DEXON RAPID (DEXON R) (May 18, 1998)
  • K974015 — ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QU (May 18, 1998)
  • K980062 — MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE (March 20, 1998)
  • K973409 — KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS (February 27, 1998)
  • K972139 — ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOP (September 3, 1997)
  • K972566 — DEXON VIOLET (August 14, 1997)
  • K962971 — POLYPROPYLENE MESH (VARIOUS SIZES) (September 16, 1996)
  • K955722 — FLEXON TEMPORARY CARDIAC PACER LEAD (March 15, 1996)

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  • K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suc (September 3, 2021)
  • K210862 — Hemafuse System (July 29, 2021)
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  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)