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510(k) K895903

IVT 0.014 GUIDE WIRE by Intensive Technology, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1990
Date Received
October 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Intensive Technology, Inc.

  • K922970 — INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM (January 13, 1993)
  • 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)
  • 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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