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FDA 510(k)

MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS

K-Number: K896443 · 1989-12-20

ApplicantPossis Medical, Inc.
Decision Date1989-12-20
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Possis Medical, Inc.. It received FDA 510(k) clearance on 1989-12-20 under 510(k) number K896443. 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 MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS?

MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS is a medical device that received FDA 510(k) clearance on 1989-12-20. The listed applicant is Possis Medical, Inc.. The 510(k) number is K896443.

When did MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS receive FDA 510(k) clearance?

MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS received FDA 510(k) clearance on 1989-12-20, under 510(k) number K896443.

Who is the listed applicant for MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS?

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

What is the FDA product code for MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS?

The FDA product code for MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS is DTB.

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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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