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 | K192313 |
| 510k Number | K192313 |
| Device Name: | Halo One Thin-Walled Guiding Sheath |
| Classification | Introducer, Catheter |
| Applicant | C.R. Bard, Inc. Moyne Upper Enniscorthy, IE |
| Contact | Elizabeth Delahunty |
| Correspondent | Elizabeth Delahunty C.R. Bard, Inc. Moyne Upper Enniscorthy, IE |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-26 |
| Decision Date | 2019-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741161964 | K192313 | 000 |
| 00801741161933 | K192313 | 000 |
| 00801741161926 | K192313 | 000 |
| 00801741161919 | K192313 | 000 |
| 00801741161889 | K192313 | 000 |
| 00801741161872 | K192313 | 000 |
| 00801741161865 | K192313 | 000 |
| 00801741161858 | K192313 | 000 |
| 00801741161841 | K192313 | 000 |
| 00801741161834 | K192313 | 000 |
| 00801741161803 | K192313 | 000 |
| 00801741161797 | K192313 | 000 |
| 00801741184871 | K192313 | 000 |
| 00801741184857 | K192313 | 000 |
| 00801741161940 | K192313 | 000 |
| 00801741161957 | K192313 | 000 |
| 00801741161902 | K192313 | 000 |
| 00801741161896 | K192313 | 000 |
| 00801741161827 | K192313 | 000 |
| 00801741161810 | K192313 | 000 |
| 10801741184878 | K192313 | 000 |
| 10801741184861 | K192313 | 000 |
| 10801741184854 | K192313 | 000 |
| 10801741184847 | K192313 | 000 |
| 10801741184830 | K192313 | 000 |
| 10801741184823 | K192313 | 000 |
| 10801741184816 | K192313 | 000 |
| 10801741184809 | K192313 | 000 |
| 00801741161971 | K192313 | 000 |
| 00801741184826 | K192313 | 000 |