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510(k) K897075

PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER by Pioneering Technologies, Inc. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1990
Date Received
December 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

Other clearances by Pioneering Technologies, Inc.

  • K922025 — ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF (September 22, 1992)
  • K905175 — PTI ANNULOPLASTY RING(STERILE) (February 14, 1992)
  • K905068 — PTI INTRA-ART (TM) PICK-UP WICKS (December 31, 1991)
  • K910067 — PTI STERNAL CLOSURE WIRE SUTURE (May 6, 1991)
  • K905067 — PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT (March 18, 1991)
  • K901682 — PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS (July 3, 1990)
  • K901815 — MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY (July 3, 1990)
  • K901531 — PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE (June 20, 1990)
  • K901575 — REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD (May 2, 1990)
  • K894684 — PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT (October 17, 1989)

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