ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER


the company

Device Classification Name

catheter, embolectomy

510(k) Number K002627
Device Name ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
Original Applicant
ATRIUM MEDICAL CORP.
5 wentworth dr.
hudson, 
NH 
03051

Original Contact rebecca dolloff
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 08/23/2000
Decision Date 04/26/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No