The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Clear Or Braided Contrast Media Injection Line With Or Without Rotator, Cath Lab Kit.
| Device ID | K011217 |
| 510k Number | K011217 |
| Device Name: | CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ABBOTT LABORATORIES DEPT. 389, AP30 200 ABBOTT PARK RD. Abbott Park, IL 60064 -3537 |
| Contact | Thomas P Sampogna |
| Correspondent | Thomas P Sampogna ABBOTT LABORATORIES DEPT. 389, AP30 200 ABBOTT PARK RD. Abbott Park, IL 60064 -3537 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-20 |
| Decision Date | 2001-05-16 |