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510(k) K883221

PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT by Pioneering Technologies, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1988
Date Received
July 29, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by Pioneering Technologies, Inc.

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  • 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)

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