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FDA 510(k)

INFUSION PUMP

K-Number: K831953 · 1983-07-19

ApplicantCryosan, Inc.
Decision Date1983-07-19
Product CodeFIR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Cryosan, Inc.. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K831953. The device is classified under product code FIR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFUSION PUMP?

INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Cryosan, Inc.. The 510(k) number is K831953.

When did INFUSION PUMP receive FDA 510(k) clearance?

INFUSION PUMP received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831953.

Who is the listed applicant for INFUSION PUMP?

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

What is the FDA product code for INFUSION PUMP?

The FDA product code for INFUSION PUMP is FIR.

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 Cryosan, 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.

K830831AUTOMATED BLOOD CELL SEPARATORK822521AUTOMATED BLOOD CELL SEPARATORK813489ROCKING/CIRCULATING CYTO-THERM II 3570K812309CRYOSAN NORMAL SALINEK812311CIRCULATING CYTO-THERMS

Related Devices (Code: FIR)

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.

K961137ATI PLASMA PUMP (PP-04)Apheresis Technologies, Inc.K830818ASAHI BLOOD/PLASMA PUMP #ABP-01A &Parker Hannifin Corp.K821139SPS-SINGLE PATIENT SYSTEMExtracorporeal Medical Specialities, Inc.K780410BLOOD PUMP-MODE S10K3M Health Care, SarnsK771705RS-7800 MINIPUMPRenal Systems, Inc.K761050HEPARIN PUMPDws, 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.

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