Home / 510(k) Clearances / K944214

510(k) K944214

BAXTER HANDLE MODEL 1150 by Baxter Edwards — Product Code DTJ

K944214 is an FDA 510(k) premarket notification submitted by Baxter Edwards for the device "BAXTER HANDLE MODEL 1150". The FDA issued a decision of Substantially Equivalent on February 10, 1995. The device falls under product code DTJ (Holder, Heart-Valve, Prosthesis), a Class I device regulated under 21 CFR 870.3935. Baxter Edwards has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1995
Date Received
August 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Heart-Valve, Prosthesis
Device Class
Class I
Regulation Number
870.3935
Review Panel
CV
Submission Type

Other clearances by Baxter Edwards

  • K993816 — BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND P (May 4, 2000)
  • K981909 — BAXTER HEMOSTASIS VALVE INTRODUCERS (November 24, 1998)
  • K980487 — CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4 (July 7, 1998)
  • K965137 — FOGARTY VALVULOTOME MODEL 700091 (June 4, 1997)
  • K964021 — INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) (March 27, 1997)
  • K955839 — MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER (March 25, 1996)
  • K952638 — 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE (July 28, 1995)
  • K944858 — BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS (January 5, 1995)
  • K940795 — SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER (May 24, 1994)
  • K926433 — 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 (March 23, 1993)

Other clearances for product code DTJ

  • K962154 — CARBOMEDICS HANDLE (August 27, 1996)
  • K960169 — CARBOMEDICS VALVE TESTER (April 15, 1996)
  • K942736 — CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE (July 6, 1994)
  • K880052 — EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR (April 1, 1988)
  • K871596 — IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) (June 15, 1987)
  • K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (November 20, 1986)
  • K813276 — IONESCU-SHILEY VALVE HOLDER & HANDLE (December 10, 1981)
  • K811236 — DISPOSABLE HOLDER FOR HANCOCK AORTIC (May 13, 1981)
  • K811235 — DISPOSABLE HOLDER FOR HANCOCK MITRAL (May 13, 1981)
  • K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER (December 7, 1979)

FDA data resources