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FDA 510(k)

MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS

K-Number: K885175 · 1989-07-14

ApplicantPossis Medical, Inc.
Decision Date1989-07-14
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL 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 1989-07-14 under 510(k) number K885175. 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 SUTURELESS MYOCARDIAL LEADS?

MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Possis Medical, Inc.. The 510(k) number is K885175.

When did MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS receive FDA 510(k) clearance?

MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS received FDA 510(k) clearance on 1989-07-14, under 510(k) number K885175.

Who is the listed applicant for MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL 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 SUTURELESS MYOCARDIAL LEADS?

The FDA product code for MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL 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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