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FDA 510(k)

ATI PLASMA PUMP (PP-04)

K-Number: K961137 · 1996-06-14

ApplicantApheresis Technologies, Inc.
Decision Date1996-06-14
Product CodeFIR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ATI PLASMA PUMP (PP-04) is the device name listed in this FDA 510(k) record. The listed applicant is Apheresis Technologies, Inc.. It received FDA 510(k) clearance on 1996-06-14 under 510(k) number K961137. 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 ATI PLASMA PUMP (PP-04)?

ATI PLASMA PUMP (PP-04) is a medical device that received FDA 510(k) clearance on 1996-06-14. The listed applicant is Apheresis Technologies, Inc.. The 510(k) number is K961137.

When did ATI PLASMA PUMP (PP-04) receive FDA 510(k) clearance?

ATI PLASMA PUMP (PP-04) received FDA 510(k) clearance on 1996-06-14, under 510(k) number K961137.

Who is the listed applicant for ATI PLASMA PUMP (PP-04)?

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

What is the FDA product code for ATI PLASMA PUMP (PP-04)?

The FDA product code for ATI PLASMA PUMP (PP-04) 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 Apheresis Technologies, 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.

K926409PLASMA DISCARD BAGS

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.

K831953INFUSION PUMPCryosan, 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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