NMK · Trocar, Reprocessed
Cardiovascular · 21 CFR 870.1390 · Class 2
Overview
| Product Code | NMK |
|---|---|
| Device Name | Trocar, Reprocessed |
| Regulation | 21 CFR 870.1390 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.
Classification Rationale
Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192998 | Reprocessed BRK Transseptal Needle | Innovative Health, LLC | Jul 22, 2020 | SESE |
Top Applicants
- Innovative Health, LLC — 1 clearance
