The following data is part of a premarket notification filed by Kimberly-clark with the FDA for Bal Cath Bronchial Aspirate Sampling Catheter.
| Device ID | K112562 |
| 510k Number | K112562 |
| Device Name: | BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER |
| Classification | Non-bronchoscopic Bronchoalveolar Lavage Catheter |
| Applicant | KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
| Contact | David Lee |
| Correspondent | David Lee KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
| Product Code | OYI |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-26 |
| Decision Date | 2011-12-15 |
| Summary: | summary |