DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET


Device Classification Name

introducer, catheter

510(k) Number K002365
Device Name DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
Original Applicant
DATASCOPE CORP.
15 law dr.
fairfield, 
NJ 
07004 -3206

Original Contact joann wolf
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 08/03/2000
Decision Date 08/25/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No