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FDA 510(k)

MODELS 1113 AND 1114 PACEMAKER LEADS

K-Number: K893763 · 1989-07-14

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

Device Summary

MODELS 1113 AND 1114 PACEMAKER 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 K893763. 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 MODELS 1113 AND 1114 PACEMAKER LEADS?

MODELS 1113 AND 1114 PACEMAKER 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 K893763.

When did MODELS 1113 AND 1114 PACEMAKER LEADS receive FDA 510(k) clearance?

MODELS 1113 AND 1114 PACEMAKER LEADS received FDA 510(k) clearance on 1989-07-14, under 510(k) number K893763.

Who is the listed applicant for MODELS 1113 AND 1114 PACEMAKER 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 MODELS 1113 AND 1114 PACEMAKER LEADS?

The FDA product code for MODELS 1113 AND 1114 PACEMAKER LEADS is DTB.

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Other records listing Possis 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.

K091593ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETSK090253ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001K082382ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039K081989MODIFICATION TO FETCH ASPIRATION CATHETERK081454GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICEK080806ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608

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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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