← Product Code [DRC](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC) · K240246

# Accusafe Transseptal Guidewire (GTR31180, GTR31230) (K240246)

_Synaptic Medical Corporation · DRC · Jul 26, 2024 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K240246

## Device Facts

- **Applicant:** Synaptic Medical Corporation
- **Product Code:** [DRC](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC.md)
- **Decision Date:** Jul 26, 2024
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1390
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K240246](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRC/K240246)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com