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510(k) K890432

DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) by Deknatel, Inc. — Product Code DWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1989
Date Received
January 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

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  • 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)
  • K926338 — PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F (July 26, 1994)
  • K930739 — SUTURES POLYPROP., POLYETHELINE, NYLON & SILK (July 26, 1994)
  • K930740 — SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL (July 26, 1994)
  • K930738 — SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC (July 26, 1994)

Other clearances for product code DWS

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  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (November 19, 1996)
  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K960139 — G.E. STERILE ANGIOGRAPHIC TRAY (April 19, 1996)
  • K960144 — G.E. STERILE CT BIOPSY TRAY (April 15, 1996)
  • K960143 — G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (April 9, 1996)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (March 19, 1990)
  • K896307 — INSULATION PAD (January 19, 1990)