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510(k) K912664

TEC ROTATING DUAL HEMOVALVE by Intensive Technology, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1992
Date Received
June 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Intensive Technology, Inc.

  • K922970 — INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM (January 13, 1993)
  • K911869 — IVT GUIDING CATHETER (October 16, 1991)
  • K903463 — IVT INTRODUCER SHEATH (January 3, 1991)
  • K904003 — HEMOCHRON(R) HEPARIN RESPONSE TEST (November 29, 1990)
  • K901767 — MODIFIED IVT PERIPHERAL ATHERECTOMY (June 28, 1990)
  • K896403 — MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM (March 6, 1990)
  • K895903 — IVT 0.014 GUIDE WIRE (January 4, 1990)
  • K892209 — APTT BY HEMOCHRON(R) (June 22, 1989)
  • K890515 — PERIPHERAL ATHERECTOMY SYSTEM (May 23, 1989)
  • K882804 — 0.014 PERIPHERAL GUIDE WIRE (October 28, 1988)

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