CARDIOVASCULAR SURGICAL INSTRUMENTS— 510(k) K874960

Name: FDA 510(k) clearance K874960
Creator: U.S. Food and Drug Administration
Published: 1988-02-05

Substantially Equivalent

Solway, Inc.

FDA 510(k) clearance K874960 for CARDIOVASCULAR SURGICAL INSTRUMENTS, Substantially Equivalent on 1988-02-05. Applicant: Solway, Inc.. Device class: 1.

Clearance details

Applicant: Solway, Inc.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1987-12-02
Decision date: 1988-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollywood, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWS

view all

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 Solway, Inc.

view all

K874962 — FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS1988-02-02
K874956 — SELF-RETAINING RETRACTOR FOR NEUROSURGERY1988-01-28
K874964 — DENTAL HAND INSTRUMENTS1988-01-27
K875043 — RONGEUR (NEUROSURGICAL INSTRUMENTS)1988-01-22
K874966 — TUNING FORKS1988-01-04

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