The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Perisafe Tuohy Epidural Needle, Bd Perisafe Weiss Epidural Needle.
| Device ID | K211085 |
| 510k Number | K211085 |
| Device Name: | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Shan Lu |
| Correspondent | Murtaza Rana Becton, Dickinson And Company 1 Becton Drive MC 237 Franklin Lakes, NJ 07417 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-12 |
| Decision Date | 2022-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382904051940 | K211085 | 000 |
| 50382904050288 | K211085 | 000 |
| 50382904050929 | K211085 | 000 |
| 50382904051858 | K211085 | 000 |
| 50382904051865 | K211085 | 000 |
| 50382904051889 | K211085 | 000 |
| 50382904051902 | K211085 | 000 |
| 50382904051919 | K211085 | 000 |
| 50382904051933 | K211085 | 000 |
| 50382904050189 | K211085 | 000 |