The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Diagnostic Catheter System.
| Device ID | K091250 |
| 510k Number | K091250 |
| Device Name: | DIAGNOSTIC CATHETER SYSTEM |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD- MPKB-3B Mcgaw Park, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-28 |
| Decision Date | 2009-05-22 |
| Summary: | summary |