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510(k) K130896

VASCULAR PROBE, VASCULAR PROBE ES by Synovis Life Technologies, Inc. — Product Code DWP

K130896 is an FDA 510(k) premarket notification submitted by Synovis Life Technologies, Inc. for the device "VASCULAR PROBE, VASCULAR PROBE ES". The FDA issued a decision of Substantially Equivalent on April 24, 2013. The device falls under product code DWP (Dilator, Vessel, Surgical), a Class II device regulated under 21 CFR 870.4475. Synovis Life Technologies, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2013
Date Received
April 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, Surgical
Device Class
Class II
Regulation Number
870.4475
Review Panel
CV
Submission Type

Other clearances by Synovis Life Technologies, Inc.

  • K223052 — Peri-Guard and Supple Peri-Guard (April 7, 2023)
  • K221032 — Vascu-Guard Vascular Repair Patch (October 19, 2022)
  • K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (October 19, 2022)
  • K143589 — GEM Flow COUPLER Device and System (January 16, 2015)
  • K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (January 7, 2015)
  • K142461 — VASCU-GUARD Peripheral Vascular Patch (November 25, 2014)
  • K142309 — GEM Flow COUPLER Device and System (September 16, 2014)
  • K132727 — GEM FLOW COUPLER DEVICE AND SYSTEM (October 22, 2013)

Other clearances for product code DWP

  • K220981 — SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (April 20, 2023)
  • K183438 — Geomed Vascular Dilators (September 3, 2019)
  • K163524 — Vessel Dilator (June 29, 2017)
  • K100518 — INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (August 31, 2010)
  • K030788 — KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (July 12, 2003)
  • K960312 — RDI CARDIAC INSULATION PAD (April 19, 1996)
  • K912548 — LEMAITRE-BOOKWALTER VESSEL DEVICES (September 18, 1991)
  • K911475 — LAPAROSCOPIC VESSEL ARTICULATOR (July 2, 1991)
  • K910682 — ROBICSEK PROBE/RETRACTOR (May 8, 1991)
  • K905159 — FLO-RESTER(R) VESSEL SIZER (February 7, 1991)

FDA data resources