K033936 is an FDA 510(k) clearance for the BARD ELIMINATOR PET BALLOON DILATORS. This device is classified as a Dilator, Esophageal (Class II - Special Controls, product code KNQ).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on January 14, 2004, 26 days after receiving the submission on December 19, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K033936 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2003 |
| Decision Date | January 14, 2004 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNQ — Dilator, Esophageal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5365 |