BIOSURGE MODEL ILVC-1— 510(k) K875016

Substantially Equivalent

Biosurge, Inc.

FDA 510(k) clearance K875016 for BIOSURGE MODEL ILVC-1, Substantially Equivalent on 1988-02-29. Applicant: Biosurge, Inc.. Device class: 1.

Clearance details

Applicant: Biosurge, Inc.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1987-12-04
Decision date: 1988-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWS

K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 106262002-10-09
K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)1997-01-30
K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS1996-11-19
K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY1996-05-15
K960139 — G.E. STERILE ANGIOGRAPHIC TRAY1996-04-19

More clearances from Biosurge, Inc.

K884620 — ASD SINGLE LUMEN NEEDLE1988-11-21
K874602 — ASD-BIO ANTI-STICK DEVICE1988-02-19
K875023 — BIOSURGE MODEL OASYS-II1988-02-12
K871258 — BIOSURGE MODEL OASYS1987-05-21

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