The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Guiding Catheter.
| Device ID | K873004 |
| 510k Number | K873004 |
| Device Name: | GUIDING CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | MALLINCKRODT CRITICAL CARE 675 MCDONNELL BLVD. P.O. BOX 5840 St Louis, MO 63134 |
| Contact | Robert S Lake |
| Correspondent | Robert S Lake MALLINCKRODT CRITICAL CARE 675 MCDONNELL BLVD. P.O. BOX 5840 St Louis, MO 63134 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-04 |
| Decision Date | 1987-09-15 |