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FDA 510(k)

STELA MODEL BJ44 AND BJ45 PACING LEADS

K-Number: K963738 · 1997-05-23

ApplicantEla Medical, Inc.
Decision Date1997-05-23
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking & PMS

Device Summary

STELA MODEL BJ44 AND BJ45 PACING LEADS 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 1997-05-23 under 510(k) number K963738. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking & PMS.

Frequently Asked Questions

What is the STELA MODEL BJ44 AND BJ45 PACING LEADS?

STELA MODEL BJ44 AND BJ45 PACING LEADS is a medical device that received FDA 510(k) clearance on 1997-05-23. The listed applicant is Ela Medical, Inc.. The 510(k) number is K963738.

When did STELA MODEL BJ44 AND BJ45 PACING LEADS receive FDA 510(k) clearance?

STELA MODEL BJ44 AND BJ45 PACING LEADS received FDA 510(k) clearance on 1997-05-23, under 510(k) number K963738.

Who is the listed applicant for STELA MODEL BJ44 AND BJ45 PACING LEADS?

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 STELA MODEL BJ44 AND BJ45 PACING LEADS?

The FDA product code for STELA MODEL BJ44 AND BJ45 PACING LEADS 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

View all 43 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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