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FDA 510(k)

UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M

K-Number: K871208 · 1987-06-05

ApplicantPacesetter Systems
Decision Date1987-06-05
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1987-06-05 under 510(k) number K871208. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M?

UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M is a medical device that received FDA 510(k) clearance on 1987-06-05. The listed applicant is Pacesetter Systems. The 510(k) number is K871208.

When did UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M receive FDA 510(k) clearance?

UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M received FDA 510(k) clearance on 1987-06-05, under 510(k) number K871208.

Who is the listed applicant for UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M?

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 UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M?

The FDA product code for UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M is DYB.

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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

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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