← Product Code [DXT](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXT) · K833138 # DIGITAL INJECTOR SYS (K833138) _Sybron Corp. · DXT · Nov 14, 1983 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXT/K833138 ## Device Facts - **Applicant:** Sybron Corp. - **Product Code:** [DXT](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXT.md) - **Decision Date:** Nov 14, 1983 - **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.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXT/K833138](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXT/K833138) **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 as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXT/K833138