TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)


Device Classification Name

catheter,intravascular,therapeutic,long-term greater than 30 days

510(k) Number K072625
Device Name TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
Applicant
COOK, INC.
750 daniels way
p.o. box 489
bloomington, 
IN 
47402

Applicant Contact karen bradburn
Correspondent
COOK, INC.
750 daniels way
p.o. box 489
bloomington, 
IN 
47402

Correspodent Contact karen bradburn
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 09/17/2007
Decision Date 12/13/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls