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FDA 510(k)

PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F

K-Number: K884394 · 1988-12-08

ApplicantEla Medical, Inc.
Decision Date1988-12-08
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F 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 1988-12-08 under 510(k) number K884394. 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 PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F?

PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F is a medical device that received FDA 510(k) clearance on 1988-12-08. The listed applicant is Ela Medical, Inc.. The 510(k) number is K884394.

When did PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F receive FDA 510(k) clearance?

PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F received FDA 510(k) clearance on 1988-12-08, under 510(k) number K884394.

Who is the listed applicant for PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F?

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 PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F?

The FDA product code for PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F 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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