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510(k) K925243

DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER by Deknatel, Inc. — Product Code GBX

K925243 is an FDA 510(k) premarket notification submitted by Deknatel, Inc. for the device "DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER". The FDA issued a decision of Substantially Equivalent on July 27, 1994. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. Deknatel, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1994
Date Received
October 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
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)
  • K930740 — SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL (July 26, 1994)
  • K930738 — SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC (July 26, 1994)
  • K926338 — PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F (July 26, 1994)
  • K930739 — SUTURES POLYPROP., POLYETHELINE, NYLON & SILK (July 26, 1994)
  • K931106 — BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT (October 6, 1993)

Other clearances for product code GBX

  • K131659 — MOERAE VEIN PREPARATION KIT (March 3, 2014)
  • K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE (December 17, 2008)
  • K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (October 21, 2005)
  • K043515 — GRAFTSAVER (March 31, 2005)
  • K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P (January 10, 2002)
  • K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (May 19, 2000)
  • K974233 — LYSONIX IRRIGATION SYSTEM (February 3, 1998)
  • K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (December 4, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)

FDA data resources