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FDA 510(k)

BIFLEX TM TEMPORARY PACING PROBE

K-Number: K790983 · 1979-07-10

ApplicantAdvanced Medical Concepts, Inc.
Decision Date1979-07-10
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIFLEX TM TEMPORARY PACING PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Concepts, Inc.. It received FDA 510(k) clearance on 1979-07-10 under 510(k) number K790983. 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 BIFLEX TM TEMPORARY PACING PROBE?

BIFLEX TM TEMPORARY PACING PROBE is a medical device that received FDA 510(k) clearance on 1979-07-10. The listed applicant is Advanced Medical Concepts, Inc.. The 510(k) number is K790983.

When did BIFLEX TM TEMPORARY PACING PROBE receive FDA 510(k) clearance?

BIFLEX TM TEMPORARY PACING PROBE received FDA 510(k) clearance on 1979-07-10, under 510(k) number K790983.

Who is the listed applicant for BIFLEX TM TEMPORARY PACING PROBE?

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

What is the FDA product code for BIFLEX TM TEMPORARY PACING PROBE?

The FDA product code for BIFLEX TM TEMPORARY PACING PROBE 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 Advanced Medical Concepts, 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.

K951768TEVES ECM PLUS THERMOCOUPLEK903671ATHANS EKG STANDARDIZER

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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