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FDA 510(k)

POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD

K-Number: K854071 · 1985-12-04

ApplicantIntermedics, Inc.
Decision Date1985-12-04
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-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 1985-12-04 under 510(k) number K854071. 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 POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD?

POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD is a medical device that received FDA 510(k) clearance on 1985-12-04. The listed applicant is Intermedics, Inc.. The 510(k) number is K854071.

When did POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD receive FDA 510(k) clearance?

POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD received FDA 510(k) clearance on 1985-12-04, under 510(k) number K854071.

Who is the listed applicant for POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-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 POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD?

The FDA product code for POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-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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