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510(k) K883412

THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) by Promedica Products, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1989
Date Received
August 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by Promedica Products, Inc.

  • K913101 — PETERS CARDIOFLON(TM) SUTURE (August 12, 1992)
  • K913102 — PETERS CARDIONYL(TM) SUTURE (August 3, 1992)
  • K892768 — PATIENT EXAMINATION GLOVES (POLY) (June 14, 1989)
  • K882882 — C-MASK (August 10, 1988)
  • K882883 — C-MASK(FLAT) (August 10, 1988)

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