← Product Code [IZQ](/productcode/IZQ) · K760643

# MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N (K760643)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · IZQ · Oct 8, 1976 · Cardiovascular · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K760643

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [IZQ](/productcode/IZQ.md)
- **Decision Date:** Oct 8, 1976
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1650
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, 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-staging.innolitics.com/device/K760643](https://fda-staging.innolitics.com/device/K760643)

**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