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510(k) K901531

PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE by Pioneering Technologies, Inc. — Product Code DNP

K901531 is an FDA 510(k) premarket notification submitted by Pioneering Technologies, Inc. for the device "PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE". The FDA issued a decision of Substantially Equivalent on June 20, 1990. The device falls under product code DNP (Thin Layer Chromatography, Ethosuximide), a Class II device regulated under 21 CFR 862.3380. Pioneering Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1990
Date Received
March 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Ethosuximide
Device Class
Class II
Regulation Number
862.3380
Review Panel
TX
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)
  • 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)

FDA data resources