SCANLAN/TAHERI VALVULOTOME— 510(k) K911184

Substantially Equivalent

Scanlan Intl., Inc.

FDA 510(k) clearance K911184 for SCANLAN/TAHERI VALVULOTOME, Substantially Equivalent on 1992-02-18. Applicant: Scanlan Intl., Inc.. Device class: 2.

Clearance details

Applicant: Scanlan Intl., Inc.
Product code: Code MGZ
Device class: Class 2
Regulation: 21 CFR 870.4885
Advisory panel: Cardiovascular
Date received: 1991-03-18
Decision date: 1992-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Paul, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Scanlan Intl., Inc.

K960372 — SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM1996-04-26
K945474 — SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER1994-12-05
K864919 — SCANLAN (TM) VEIN/GRAFT HOLDER1987-01-12
K864920 — SCANLAN (TM) INSTRUMENT TRAY1987-01-12
K851825 — SCANLAN TUNNELER, SHEATH & TIP1985-07-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.