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510(k) K922970

INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM by Intensive Technology, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1993
Date Received
June 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peripheral, Atherectomy
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

Other clearances by Intensive Technology, Inc.

  • K912664 — TEC ROTATING DUAL HEMOVALVE (August 24, 1992)
  • 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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