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)

LANCASTER COOLING JACKET, CAT. CODE #13500/13501

K-Number: K913077 · 1992-01-09

ApplicantDlp, Inc.
Decision Date1992-01-09
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LANCASTER COOLING JACKET, CAT. CODE #13500/13501 is the device name listed in this FDA 510(k) record. The listed applicant is Dlp, Inc.. It received FDA 510(k) clearance on 1992-01-09 under 510(k) number K913077. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LANCASTER COOLING JACKET, CAT. CODE #13500/13501?

LANCASTER COOLING JACKET, CAT. CODE #13500/13501 is a medical device that received FDA 510(k) clearance on 1992-01-09. The listed applicant is Dlp, Inc.. The 510(k) number is K913077.

When did LANCASTER COOLING JACKET, CAT. CODE #13500/13501 receive FDA 510(k) clearance?

LANCASTER COOLING JACKET, CAT. CODE #13500/13501 received FDA 510(k) clearance on 1992-01-09, under 510(k) number K913077.

Who is the listed applicant for LANCASTER COOLING JACKET, CAT. CODE #13500/13501?

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

What is the FDA product code for LANCASTER COOLING JACKET, CAT. CODE #13500/13501?

The FDA product code for LANCASTER COOLING JACKET, CAT. CODE #13500/13501 is DTR.

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 Dlp, 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.

K973485CLEARVIEW BLOWER/MISTERK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLETK950754MACRO SUCTION TUBE MODEL NO 10061K934215CONTAIN-ORK915268CATHETER TWO STAGE VENOUS RETURN

View all 56 devices →

Related Devices (Code: DTR)

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.

K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L.K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)Spectrum Medical , Ltd.K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)Sorin Group Italia S.R.L.K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System UncoatedMedtronicK223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L

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.

↑