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 | K161183 |
| 510k Number | K161183 |
| Device Name: | Halo One Thin-Walled Guiding Sheath |
| Classification | Introducer, Catheter |
| Applicant | C.R. BARD, INC MOYNE UPPER Enniscorthy, IE |
| Contact | Fiona Ni Mhullain |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-04-27 |
| Decision Date | 2016-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741111549 | K161183 | 000 |
| 00801741111525 | K161183 | 000 |