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FDA 510(k)

MODEL FF..D & FX..D PACEMAKER LEADS

K-Number: K823896 · 1983-04-30

ApplicantDr. Ing. P. Osypka, GmbH
Decision Date1983-04-30
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL FF..D & FX..D PACEMAKER LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Ing. P. Osypka, GmbH. It received FDA 510(k) clearance on 1983-04-30 under 510(k) number K823896. 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 MODEL FF..D & FX..D PACEMAKER LEADS?

MODEL FF..D & FX..D PACEMAKER LEADS is a medical device that received FDA 510(k) clearance on 1983-04-30. The listed applicant is Dr. Ing. P. Osypka, GmbH. The 510(k) number is K823896.

When did MODEL FF..D & FX..D PACEMAKER LEADS receive FDA 510(k) clearance?

MODEL FF..D & FX..D PACEMAKER LEADS received FDA 510(k) clearance on 1983-04-30, under 510(k) number K823896.

Who is the listed applicant for MODEL FF..D & FX..D PACEMAKER LEADS?

The FDA 510(k) record lists Dr. Ing. P. Osypka, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL FF..D & FX..D PACEMAKER LEADS?

The FDA product code for MODEL FF..D & FX..D PACEMAKER LEADS 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 Dr. Ing. P. Osypka, GmbH 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.

K823894MODEL RZ PACEMAKER LEAD VARIOUSK823892MODEL SZ PACEMAKER LEAD-VARIOUS

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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