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)

CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD

K-Number: K851897 · 1985-08-09

ApplicantCardiac Control Systems, Inc.
Decision Date1985-08-09
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Control Systems, Inc.. It received FDA 510(k) clearance on 1985-08-09 under 510(k) number K851897. 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 CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD?

CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD is a medical device that received FDA 510(k) clearance on 1985-08-09. The listed applicant is Cardiac Control Systems, Inc.. The 510(k) number is K851897.

When did CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD receive FDA 510(k) clearance?

CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD received FDA 510(k) clearance on 1985-08-09, under 510(k) number K851897.

Who is the listed applicant for CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD?

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

What is the FDA product code for CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD?

The FDA product code for CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD 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 Cardiac Control Systems, 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.

K971775INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610K946188CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKERK950210CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKERK923868CCS MAESTRO II SERIES 200 CARDIAC PACEMAKERK905824MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKEK904941MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE

View all 26 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.

↑