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FDA 510(k)

POLY FLEX IMPLANTABLE PACING LEAD

K-Number: K802294 · 1985-04-03

ApplicantIntermedics, Inc.
Decision Date1985-04-03
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLY FLEX IMPLANTABLE PACING LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1985-04-03 under 510(k) number K802294. 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 POLY FLEX IMPLANTABLE PACING LEAD?

POLY FLEX IMPLANTABLE PACING LEAD is a medical device that received FDA 510(k) clearance on 1985-04-03. The listed applicant is Intermedics, Inc.. The 510(k) number is K802294.

When did POLY FLEX IMPLANTABLE PACING LEAD receive FDA 510(k) clearance?

POLY FLEX IMPLANTABLE PACING LEAD received FDA 510(k) clearance on 1985-04-03, under 510(k) number K802294.

Who is the listed applicant for POLY FLEX IMPLANTABLE PACING LEAD?

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

What is the FDA product code for POLY FLEX IMPLANTABLE PACING LEAD?

The FDA product code for POLY FLEX IMPLANTABLE PACING LEAD is DTB.

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Other records listing Intermedics, 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

View all 211 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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