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510(k) K914210

VAS-CATH DUALATOR(TM) VESSEL DILATOR by Vas-Cath, Inc. — Product Code FKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1993
Date Received
September 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
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)
  • K925485 — VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER (March 10, 1994)
  • K933483 — OPTI-PLAST 5F PTA CATHETERS (September 24, 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)

Other clearances for product code FKA

  • K022620 — SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIK (October 11, 2002)
  • K910502 — VESSEL DILATORS (April 29, 1991)