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FDA 510(k)

MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD

K-Number: K885240 · 1989-02-10

ApplicantTpl-Cordis, Inc.
Decision Date1989-02-10
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Tpl-Cordis, Inc.. It received FDA 510(k) clearance on 1989-02-10 under 510(k) number K885240. 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 MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD?

MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD is a medical device that received FDA 510(k) clearance on 1989-02-10. The listed applicant is Tpl-Cordis, Inc.. The 510(k) number is K885240.

When did MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD receive FDA 510(k) clearance?

MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD received FDA 510(k) clearance on 1989-02-10, under 510(k) number K885240.

Who is the listed applicant for MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD?

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

What is the FDA product code for MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD?

The FDA product code for MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD is DTB.

Related Clinical Trials

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.

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Other records listing Tpl-Cordis, 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.

K882429MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004K880898MULTICOR AND PACEMAKERSK880432VICOR PACER, MODEL 410AK873158MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERSK873202VICOR, MODEL 410A

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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