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FDA 510(k)

LEAD MODELS MUM 1260, MUM 1290

K-Number: K790386 · 1979-04-03

ApplicantEla Medical, Inc.
Decision Date1979-04-03
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEAD MODELS MUM 1260, MUM 1290 is the device name listed in this FDA 510(k) record. The listed applicant is Ela Medical, Inc.. It received FDA 510(k) clearance on 1979-04-03 under 510(k) number K790386. 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 LEAD MODELS MUM 1260, MUM 1290?

LEAD MODELS MUM 1260, MUM 1290 is a medical device that received FDA 510(k) clearance on 1979-04-03. The listed applicant is Ela Medical, Inc.. The 510(k) number is K790386.

When did LEAD MODELS MUM 1260, MUM 1290 receive FDA 510(k) clearance?

LEAD MODELS MUM 1260, MUM 1290 received FDA 510(k) clearance on 1979-04-03, under 510(k) number K790386.

Who is the listed applicant for LEAD MODELS MUM 1260, MUM 1290?

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

What is the FDA product code for LEAD MODELS MUM 1260, MUM 1290?

The FDA product code for LEAD MODELS MUM 1260, MUM 1290 is DTB.

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Other records listing Ela Medical, 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.

K042002SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADERK032466SPIDERVIEWK002817SYNETECK993448STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK000029STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK990727SYNEFLASH & SYNEVIEW

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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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