UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE— 510(k) K881796

Name: FDA 510(k) clearance K881796
Creator: U.S. Food and Drug Administration
Published: 1988-07-26

Substantially Equivalent

Universal Medical Instrument Corp.

FDA 510(k) clearance K881796 for UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE, Substantially Equivalent on 1988-07-26. Applicant: Universal Medical Instrument Corp.. Device class: 1.

Clearance details

Applicant: Universal Medical Instrument Corp.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1988-04-27
Decision date: 1988-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballston Spa, NY, 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 Universal Medical Instrument Corp.

view all

K962180 — CATH SEAL1996-11-07
K935077 — CATH-SEAL1994-06-07
K897128 — UMI BRAIDED CATHETER CONNECTOR1990-03-01
K863178 — UMI STEERABLE TORQUE GUIDE WIRE1986-09-19
K861984 — UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO1986-08-05

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