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510(k) K885046

INSITUCAT VALVE STRIPPER by Aesculap Instruments Corp. — Product Code DWQ

K885046 is an FDA 510(k) premarket notification submitted by Aesculap Instruments Corp. for the device "INSITUCAT VALVE STRIPPER". The FDA issued a decision of Substantially Equivalent on February 28, 1990. The device falls under product code DWQ (Stripper, Vein, External), a Class II device regulated under 21 CFR 870.4885. Aesculap Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1990
Date Received
December 5, 1988
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 Aesculap Instruments Corp.

  • K890182 — PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV (February 28, 1990)
  • K890443 — CASPAR SCALP CLIP, APPLIER (June 15, 1989)
  • K893121 — ROBOTRAC (TM) RETRACTOR ARM (June 1, 1989)
  • K884057 — ELAN-E DISPOSABLE DRAPE (October 19, 1988)
  • K880704 — CERULLO SUCTION REGULATOR (March 29, 1988)
  • K860016 — AESCULAP BONE MILL (March 19, 1986)
  • K801888 — HANDPIECE, DENTAL (August 20, 1980)
  • K801886 — BURR, DENTAL (August 20, 1980)
  • K801887 — DRILL, DENTAL (August 20, 1980)
  • K792558 — CONTAINER SYSTEM (December 27, 1979)

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)
  • K872157 — HALL VEIN STRIPPER (July 7, 1987)
  • K811910 — VEIN-TRAP TM (July 20, 1981)

FDA data resources