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510(k) K904507

PILLING BRUSH VALVULOTOME by Pilling Co. — Product Code DWQ

K904507 is an FDA 510(k) premarket notification submitted by Pilling Co. for the device "PILLING BRUSH VALVULOTOME". The FDA issued a decision of Substantially Equivalent on March 1, 1991. The device falls under product code DWQ (Stripper, Vein, External), a Class II device regulated under 21 CFR 870.4885. Pilling Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1991
Date Received
October 2, 1990
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 Pilling Co.

  • K002582 — PILLING E-FRAZIER BIPOLAR SUCTION TUBE (November 3, 2000)
  • K934427 — PILLING LAPAROSCOPIC INSTRUMENTATION (January 10, 1994)
  • K925370 — TRIANGULAR JAW MICROLARYNGEAL FORCEPS (March 18, 1993)
  • K925198 — KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR (February 12, 1993)
  • K922971 — NO-SCALPEL VASCETOMY INSTRUMENTS (September 23, 1992)
  • K914015 — CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP (November 21, 1991)
  • K911099 — MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE (June 25, 1991)
  • K911100 — MEHIGAN-PILLING PHLEBETOME TM (June 21, 1991)
  • K884946 — JEHLE CORONARY PERFUSION CATHETERS (February 6, 1989)
  • K882930 — LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX (August 16, 1988)

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)
  • K885046 — INSITUCAT VALVE STRIPPER (February 28, 1990)
  • K872157 — HALL VEIN STRIPPER (July 7, 1987)
  • K811910 — VEIN-TRAP TM (July 20, 1981)

FDA data resources