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510(k) K924337

PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS by Deknatel, Inc. — Product Code GCX

K924337 is an FDA 510(k) premarket notification submitted by Deknatel, Inc. for the device "PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS". The FDA issued a decision of Substantially Equivalent on July 28, 1993. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Deknatel, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1993
Date Received
August 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Deknatel, Inc.

  • K963850 — PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (April 22, 1997)
  • K962683 — SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR (January 10, 1997)
  • K964070 — DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG (December 31, 1996)
  • K963098 — PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM( (November 8, 1996)
  • K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2- (August 28, 1996)
  • K925243 — DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER (July 27, 1994)
  • K930740 — SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL (July 26, 1994)
  • K926338 — PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F (July 26, 1994)
  • K930738 — SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC (July 26, 1994)
  • K930739 — SUTURES POLYPROP., POLYETHELINE, NYLON & SILK (July 26, 1994)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)

FDA data resources