SCANLAN ENDARSECTOR— 510(k) K841521

Substantially Equivalent

Scanlan Intl., Inc.

FDA 510(k) clearance K841521 for SCANLAN ENDARSECTOR, Substantially Equivalent on 1984-08-03. Applicant: Scanlan Intl., Inc.. Device class: 2.

Clearance details

Applicant: Scanlan Intl., Inc.
Product code: Code DWX
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 1984-04-12
Decision date: 1984-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K911184 — SCANLAN/TAHERI VALVULOTOME1992-02-18
K864919 — SCANLAN (TM) VEIN/GRAFT HOLDER1987-01-12
K864920 — SCANLAN (TM) INSTRUMENT TRAY1987-01-12

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