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)

PERMATHANE 865 & 867 UNIPOLAR POLYURETH

K-Number: K843703 · 1985-01-08

ApplicantPacesetter Systems
Decision Date1985-01-08
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERMATHANE 865 & 867 UNIPOLAR POLYURETH is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1985-01-08 under 510(k) number K843703. The device is classified under product code DTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMATHANE 865 & 867 UNIPOLAR POLYURETH?

PERMATHANE 865 & 867 UNIPOLAR POLYURETH is a medical device that received FDA 510(k) clearance on 1985-01-08. The listed applicant is Pacesetter Systems. The 510(k) number is K843703.

When did PERMATHANE 865 & 867 UNIPOLAR POLYURETH receive FDA 510(k) clearance?

PERMATHANE 865 & 867 UNIPOLAR POLYURETH received FDA 510(k) clearance on 1985-01-08, under 510(k) number K843703.

Who is the listed applicant for PERMATHANE 865 & 867 UNIPOLAR POLYURETH?

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

What is the FDA product code for PERMATHANE 865 & 867 UNIPOLAR POLYURETH?

The FDA product code for PERMATHANE 865 & 867 UNIPOLAR POLYURETH is DTD.

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 Pacesetter Systems 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.

K910924ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONEK902147ENDOCARDIAL SCREW-IN LEAD MODEL 1028TK900512SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERSK900550FAST-PASS ACE MODELS 1212T/1222T/1216T/1226TK895447ENDOCARDIAL SCREW-IN LEAD MODEL 1020TK891905CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

View all 96 devices →

Related Devices (Code: DTD)

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.

K1320086981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAPMedtronic, Inc.K041574CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020Guidant CorporationK031164PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLVOscor, Inc.K024156PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAROscor, Inc.K010787PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONSOscor, Inc.K003454A1-CS-SB Y-ADAPTER, MODEL 124 871Biotronik, 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.

↑