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510(k) K911100

MEHIGAN-PILLING PHLEBETOME TM by Pilling Co. — Product Code MGZ

K911100 is an FDA 510(k) premarket notification submitted by Pilling Co. for the device "MEHIGAN-PILLING PHLEBETOME TM". The FDA issued a decision of Substantially Equivalent on June 21, 1991. The device falls under product code MGZ (Valvulotome), 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
June 21, 1991
Date Received
March 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valvulotome
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)
  • K904507 — PILLING BRUSH VALVULOTOME (March 1, 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 MGZ

  • K260188 — LimFlow Vector (March 18, 2026)
  • K250105 — Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) (July 3, 2025)
  • K221902 — LimFlow Vector (December 21, 2022)
  • K190267 — EZE SIT Valvulotome (October 30, 2019)
  • K142660 — Antegrade LeMills Valvulotome (October 17, 2014)
  • K140042 — 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (April 10, 2014)
  • K132047 — LEMILLS VALVULOTOME (November 5, 2013)
  • K132190 — EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME (August 5, 2013)
  • K111884 — OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME (July 29, 2011)
  • K080178 — VALVULOTOME BY KOVEN (July 28, 2008)

FDA data resources