Accusafe Transseptal Guidewire (GTR31180, GTR31230)
Device Facts
| Record ID | K240246 |
|---|---|
| Device Name | Accusafe Transseptal Guidewire (GTR31180, GTR31230) |
| Applicant | Synaptic Medical Corporation |
| Product Code | DRC · Cardiovascular |
| Decision Date | Jul 26, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1390 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.
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.
