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)

CRYOBAG

K-Number: K915471 · 1994-03-02

ApplicantJanus Biomedical, Inc.
Decision Date1994-03-02
Product CodeLPZ
DecisionSubstantially Equivalent

Device Summary

CRYOBAG is the device name listed in this FDA 510(k) record. The listed applicant is Janus Biomedical, Inc.. It received FDA 510(k) clearance on 1994-03-02 under 510(k) number K915471. The device is classified under product code LPZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOBAG?

CRYOBAG is a medical device that received FDA 510(k) clearance on 1994-03-02. The listed applicant is Janus Biomedical, Inc.. The 510(k) number is K915471.

When did CRYOBAG receive FDA 510(k) clearance?

CRYOBAG received FDA 510(k) clearance on 1994-03-02, under 510(k) number K915471.

Who is the listed applicant for CRYOBAG?

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

What is the FDA product code for CRYOBAG?

The FDA product code for CRYOBAG is LPZ.

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 Janus Biomedical, 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.

K943803JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM

Related Devices (Code: LPZ)

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.

K021702CRYOBAG, MODEL CBOrigen Biomedical, Inc.K863872TAMPER HAMPERHydro-Med Products, Inc.K861761ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGETravenol Laboratories, S.A.K860511AMPU-PAKAmmerman Medical Enterprises, Inc.K853663ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STORTravenol Laboratories, S.A.

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.

↑