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)

IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069

K-Number: K950140 · 1995-04-06

ApplicantPacesetter, Inc.
Decision Date1995-04-06
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter, Inc.. It received FDA 510(k) clearance on 1995-04-06 under 510(k) number K950140. 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 IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069?

IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 is a medical device that received FDA 510(k) clearance on 1995-04-06. The listed applicant is Pacesetter, Inc.. The 510(k) number is K950140.

When did IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 receive FDA 510(k) clearance?

IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 received FDA 510(k) clearance on 1995-04-06, under 510(k) number K950140.

Who is the listed applicant for IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069?

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

What is the FDA product code for IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069?

The FDA product code for IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 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, 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.

K972814LOCATOR MODEL 4036K960854SIEMENS SERVO ULTRA NEBULIZER 345K954714AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)K954551DF-1 TERMINAL CAPK951950PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATINGK952206PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING

View all 8 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.

↑