GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4


Device Classification Name

device, neurovascular embolization

510(k) Number K001083
Device Name GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4
Original Applicant
BOSTON SCIENTIFIC, TARGET
47900 bayside pkwy.
fremont, 
CA 
94538

Original Contact james leathley
Regulation Number 882.5950
Classification Product Code
HCG  
Date Received 04/04/2000
Decision Date 05/03/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Special
Reviewed by Third Party No

Combination Product

No