FDA 510(k)

CASTALERT

K-Number: K861292 · 1986-05-12

Decision Date1986-05-12

Product Code

DecisionSubstantially Equivalent

Device Summary

CASTALERT is the device name listed in this FDA 510(k) record. The listed applicant is Walgen Medical Innoventions. It received FDA 510(k) clearance on 1986-05-12 under 510(k) number K861292. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASTALERT?

CASTALERT is a medical device that received FDA 510(k) clearance on 1986-05-12. The listed applicant is Walgen Medical Innoventions. The 510(k) number is K861292.

When did CASTALERT receive FDA 510(k) clearance?

CASTALERT received FDA 510(k) clearance on 1986-05-12, under 510(k) number K861292.

Who is the listed applicant for CASTALERT?

The FDA 510(k) record lists Walgen Medical Innoventions as the applicant. This does not by itself establish the device manufacturer.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Walgen Medical Innoventions as applicant

K810433LOWER EXTREMITY SUPPORT SYSTEM-LESS K810542CEMENT FUME EVACUATOR TANK & FILTER

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.