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510(k) K922025

ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF by Pioneering Technologies, Inc. — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1992
Date Received
April 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

Other clearances by Pioneering Technologies, Inc.

  • 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)
  • K897075 — PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER (April 10, 1990)
  • K894684 — PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT (October 17, 1989)

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