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)

DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER

K-Number: K925243 · 1994-07-27

ApplicantDeknatel, Inc.
Decision Date1994-07-27
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1994-07-27 under 510(k) number K925243. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER?

DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER is a medical device that received FDA 510(k) clearance on 1994-07-27. The listed applicant is Deknatel, Inc.. The 510(k) number is K925243.

When did DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER receive FDA 510(k) clearance?

DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER received FDA 510(k) clearance on 1994-07-27, under 510(k) number K925243.

Who is the listed applicant for DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER?

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 DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER?

The FDA product code for DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER is GBX.

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 AUTOTRK930738SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC

View all 37 devices →

Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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.

↑