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)

PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM

K-Number: K883082 · 1988-10-13

ApplicantDeknatel, Inc.
Decision Date1988-10-13
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1988-10-13 under 510(k) number K883082. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM?

PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM is a medical device that received FDA 510(k) clearance on 1988-10-13. The listed applicant is Deknatel, Inc.. The 510(k) number is K883082.

When did PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM receive FDA 510(k) clearance?

PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM received FDA 510(k) clearance on 1988-10-13, under 510(k) number K883082.

Who is the listed applicant for PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM?

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

What is the FDA product code for PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM?

The FDA product code for PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM is CAC.

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 Deknatel, 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.

K963850PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMK962683SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATORK964070DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAGK963098PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRK925243DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER

View all 37 devices →

Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

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.

↑