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510(k) K811910

VEIN-TRAP TM by Atrium Medical Corp. — Product Code DWQ

K811910 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "VEIN-TRAP TM". The FDA issued a decision of Substantially Equivalent on July 20, 1981. The device falls under product code DWQ (Stripper, Vein, External), a Class II device regulated under 21 CFR 870.4885. Atrium Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1981
Date Received
July 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stripper, Vein, External
Device Class
Class II
Regulation Number
870.4885
Review Panel
CV
Submission Type

Other clearances by Atrium Medical Corp.

  • K130131 — EDRAIN CHEST DRAINAGE SYSTEM (February 28, 2013)
  • K122138 — ATRIUM FLIXENE IFG VASCULAR GRAFT (August 17, 2012)
  • K121070 — C-QUR RPM MESH (April 26, 2012)
  • K113112 — CLEARWAY RX NB CATHETER (November 17, 2011)
  • K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT (October 5, 2010)
  • K093431 — CLEARWAY OTW MODEL 85912 (April 20, 2010)
  • K100076 — ATRIUM C-QUR OVT MESH (January 26, 2010)
  • K090909 — C-QUR V -PATCH MESH (June 4, 2009)
  • K082748 — ATRIUM PROLITE S MESH (January 14, 2009)
  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)

Other clearances for product code DWQ

  • K212894 — PhasTIPP (March 31, 2022)
  • K041453 — SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 (July 22, 2004)
  • K032387 — TRIVEX SYSTEM (October 29, 2003)
  • K905528 — URESIL VALVE CUTTER (April 18, 1991)
  • K904507 — PILLING BRUSH VALVULOTOME (March 1, 1991)
  • K885046 — INSITUCAT VALVE STRIPPER (February 28, 1990)
  • K872157 — HALL VEIN STRIPPER (July 7, 1987)

FDA data resources