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FDA 510(k)

POLYSAFE(TM) IMPLANTABLE PACING LEAD

K-Number: K884024 · 1988-10-14

ApplicantCardiac Control Systems, Inc.
Decision Date1988-10-14
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLYSAFE(TM) IMPLANTABLE PACING 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 1988-10-14 under 510(k) number K884024. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYSAFE(TM) IMPLANTABLE PACING LEAD?

POLYSAFE(TM) IMPLANTABLE PACING LEAD is a medical device that received FDA 510(k) clearance on 1988-10-14. The listed applicant is Cardiac Control Systems, Inc.. The 510(k) number is K884024.

When did POLYSAFE(TM) IMPLANTABLE PACING LEAD receive FDA 510(k) clearance?

POLYSAFE(TM) IMPLANTABLE PACING LEAD received FDA 510(k) clearance on 1988-10-14, under 510(k) number K884024.

Who is the listed applicant for POLYSAFE(TM) IMPLANTABLE PACING 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 POLYSAFE(TM) IMPLANTABLE PACING LEAD?

The FDA product code for POLYSAFE(TM) IMPLANTABLE PACING LEAD is DTB.

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: DTB)

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.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, 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.

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