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FDA 510(k)

APEX ALPHA VACUUM PUMP

K-Number: K871570 · 1987-08-18

ApplicantApex Medical, Inc.
Decision Date1987-08-18
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

APEX ALPHA VACUUM PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical, Inc.. It received FDA 510(k) clearance on 1987-08-18 under 510(k) number K871570. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEX ALPHA VACUUM PUMP?

APEX ALPHA VACUUM PUMP is a medical device that received FDA 510(k) clearance on 1987-08-18. The listed applicant is Apex Medical, Inc.. The 510(k) number is K871570.

When did APEX ALPHA VACUUM PUMP receive FDA 510(k) clearance?

APEX ALPHA VACUUM PUMP received FDA 510(k) clearance on 1987-08-18, under 510(k) number K871570.

Who is the listed applicant for APEX ALPHA VACUUM PUMP?

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

What is the FDA product code for APEX ALPHA VACUUM PUMP?

The FDA product code for APEX ALPHA VACUUM PUMP is BTA.

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 Apex Medical, 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.

K933965APEX MEDICAL AIR PUMPSK902102COM-TENS: A NEUROSTIMULATORK882816PULSAR EMK882468ELIMINATOR AIR FILTERK871384APEX SUCTION CURETTE

Related Devices (Code: BTA)

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.

K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.

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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