Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VERSA-VIAL

K-Number: K920177 · 1992-07-13

ApplicantBioteque America, Inc.
Decision Date1992-07-13
Product CodeDQF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VERSA-VIAL is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque America, Inc.. It received FDA 510(k) clearance on 1992-07-13 under 510(k) number K920177. The device is classified under product code DQF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSA-VIAL?

VERSA-VIAL is a medical device that received FDA 510(k) clearance on 1992-07-13. The listed applicant is Bioteque America, Inc.. The 510(k) number is K920177.

When did VERSA-VIAL receive FDA 510(k) clearance?

VERSA-VIAL received FDA 510(k) clearance on 1992-07-13, under 510(k) number K920177.

Who is the listed applicant for VERSA-VIAL?

The FDA 510(k) record lists Bioteque America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERSA-VIAL?

The FDA product code for VERSA-VIAL is DQF.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bioteque America, Inc. as applicant

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.

K041094HSG CATHETER SETK020628CURELLE, PREFERRED CURELLE, CUTEQ 2.5K013289BIOTEQUE VAGINAL PESSARIESK003380BIOTEQUE VAGINAL DILATORK920633PESSARY FLEXIBLE SILICONE NICHOLSK920747PESSARY FLEXIBLE SILICONE DONUT RING

View all 10 devices →

Related Devices (Code: DQF)

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.

K882723ALCON FLUID INJECTORAlcon LaboratoriesK880740MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGESpectramed, Inc.

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.

↑