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510(k) K953608

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER by Meadox Medicals, Div. Boston Scientific Corp. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1995
Date Received
August 2, 1995
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 Meadox Medicals, Div. Boston Scientific Corp.

  • K953647 — MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING (May 16, 1997)
  • K960766 — MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (March 19, 1997)
  • K962433 — MEADOX EXXCEL EPTFE VASCULAR GRAFT (March 17, 1997)
  • K961847 — HEMASHIELD VANTAGE (VASCULAR GRAFT (January 22, 1997)
  • K962342 — HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH (September 10, 1996)
  • K955460 — MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GR (May 30, 1996)
  • K952884 — NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER (February 21, 1996)
  • K955349 — HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC (February 14, 1996)
  • K953298 — MS CLASSIQUE BALLOON DIATATION CATHETER (February 8, 1996)
  • K954848 — HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT (February 1, 1996)

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