The following data is part of a premarket notification filed by C.r.bard, Inc with the FDA for Halo One Thin-walled Guiding Sheath.
| Device ID | K212708 |
| 510k Number | K212708 |
| Device Name: | Halo One Thin-Walled Guiding Sheath |
| Classification | Introducer, Catheter |
| Applicant | C.R.Bard, Inc Moyne Upper Enniscorthy, IE |
| Contact | Annmarie Fitzgerald |
| Correspondent | Annmarie Fitzgerald C.R.Bard, Inc Moyne Upper Enniscorthy, IE |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-26 |
| Decision Date | 2021-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741223891 | K212708 | 000 |
| 10801741223782 | K212708 | 000 |
| 00801741223792 | K212708 | 000 |
| 00801741223808 | K212708 | 000 |
| 10801741223812 | K212708 | 000 |
| 10801741223829 | K212708 | 000 |
| 00801741223839 | K212708 | 000 |
| 00801741223846 | K212708 | 000 |
| 10801741223850 | K212708 | 000 |
| 00801741223860 | K212708 | 000 |
| 10801741223904 | K212708 | 000 |
| 00801741223914 | K212708 | 000 |
| 00801741218293 | K212708 | 000 |
| 00801741218309 | K212708 | 000 |
| 00801741218316 | K212708 | 000 |
| 10801741219136 | K212708 | 000 |
| 00801741223877 | K212708 | 000 |
| 00801741223884 | K212708 | 000 |
| 10801741223775 | K212708 | 000 |