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FDA 510(k)

ENDOCARDIAL CARBON-TIP LEAD

K-Number: K861481 · 1986-06-06

ApplicantPacesetter Systems
Decision Date1986-06-06
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENDOCARDIAL CARBON-TIP LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1986-06-06 under 510(k) number K861481. 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 ENDOCARDIAL CARBON-TIP LEAD?

ENDOCARDIAL CARBON-TIP LEAD is a medical device that received FDA 510(k) clearance on 1986-06-06. The listed applicant is Pacesetter Systems. The 510(k) number is K861481.

When did ENDOCARDIAL CARBON-TIP LEAD receive FDA 510(k) clearance?

ENDOCARDIAL CARBON-TIP LEAD received FDA 510(k) clearance on 1986-06-06, under 510(k) number K861481.

Who is the listed applicant for ENDOCARDIAL CARBON-TIP LEAD?

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 ENDOCARDIAL CARBON-TIP LEAD?

The FDA product code for ENDOCARDIAL CARBON-TIP LEAD is DTB.

Related Clinical Trials

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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: 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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