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510(k) K183438

Geomed Vascular Dilators by Geomed Medizin-Technik GmbH & Co. — Product Code DWP

K183438 is an FDA 510(k) premarket notification submitted by Geomed Medizin-Technik GmbH & Co. for the device "Geomed Vascular Dilators". The FDA issued a decision of Substantially Equivalent on September 3, 2019. The device falls under product code DWP (Dilator, Vessel, Surgical), a Class II device regulated under 21 CFR 870.4475. Geomed Medizin-Technik GmbH & Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2019
Date Received
December 12, 2018
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 Geomed Medizin-Technik GmbH & Co.

  • K052745 — ASSISTO ARM SYSTEMS (November 23, 2005)

Other clearances for product code DWP

  • K220981 — SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (April 20, 2023)
  • K163524 — Vessel Dilator (June 29, 2017)
  • K130896 — VASCULAR PROBE, VASCULAR PROBE ES (April 24, 2013)
  • 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