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510(k) K925485

VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER by Vas-Cath, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1994
Date Received
October 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Vas-Cath, Inc.

  • K973013 — OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER (June 19, 1998)
  • K965178 — NIAGARA DUAL LUMEN CATHETER (August 19, 1997)
  • K964881 — ULTRAVERSE PTA CATHETER (May 28, 1997)
  • K970725 — OPTI-PLAST XL 5.5 F PTA CATHETER (May 9, 1997)
  • K941706 — OPTI-PLAST ANGIOPLASTY CATHETER (October 18, 1994)
  • K933483 — OPTI-PLAST 5F PTA CATHETERS (September 24, 1993)
  • K914210 — VAS-CATH DUALATOR(TM) VESSEL DILATOR (July 1, 1993)
  • K914162 — VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS (July 1, 1993)
  • K914976 — OPTI-PLAST 5F PTA CATHETERS, MODIFICATION (January 27, 1992)
  • K914500 — OPTI-PLAST 5F PTA CATHETERS, MODIFICATION (December 31, 1991)

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