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)

EDRAIN CHEST DRAINAGE SYSTEM

K-Number: K130131 · 2013-02-28

ApplicantAtrium Medical Corp.
Decision Date2013-02-28
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EDRAIN CHEST DRAINAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 2013-02-28 under 510(k) number K130131. 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 EDRAIN CHEST DRAINAGE SYSTEM?

EDRAIN CHEST DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-28. The listed applicant is Atrium Medical Corp.. The 510(k) number is K130131.

When did EDRAIN CHEST DRAINAGE SYSTEM receive FDA 510(k) clearance?

EDRAIN CHEST DRAINAGE SYSTEM received FDA 510(k) clearance on 2013-02-28, under 510(k) number K130131.

Who is the listed applicant for EDRAIN CHEST DRAINAGE SYSTEM?

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

What is the FDA product code for EDRAIN CHEST DRAINAGE SYSTEM?

The FDA product code for EDRAIN CHEST DRAINAGE SYSTEM 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 Atrium Medical Corp. 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.

K122138ATRIUM FLIXENE IFG VASCULAR GRAFTK121070C-QUR RPM MESHK113112CLEARWAY RX NB CATHETERK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912K100076ATRIUM C-QUR OVT MESH

View all 63 devices →

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.

↑