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FDA 510(k)

PACING LEAD MODELS SA, 350, SAM 500

K-Number: K781619 · 1978-12-08

ApplicantR.E. Brown Co., Inc.
Decision Date1978-12-08
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACING LEAD MODELS SA, 350, SAM 500 is the device name listed in this FDA 510(k) record. The listed applicant is R.E. Brown Co., Inc.. It received FDA 510(k) clearance on 1978-12-08 under 510(k) number K781619. 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 PACING LEAD MODELS SA, 350, SAM 500?

PACING LEAD MODELS SA, 350, SAM 500 is a medical device that received FDA 510(k) clearance on 1978-12-08. The listed applicant is R.E. Brown Co., Inc.. The 510(k) number is K781619.

When did PACING LEAD MODELS SA, 350, SAM 500 receive FDA 510(k) clearance?

PACING LEAD MODELS SA, 350, SAM 500 received FDA 510(k) clearance on 1978-12-08, under 510(k) number K781619.

Who is the listed applicant for PACING LEAD MODELS SA, 350, SAM 500?

The FDA 510(k) record lists R.E. Brown Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACING LEAD MODELS SA, 350, SAM 500?

The FDA product code for PACING LEAD MODELS SA, 350, SAM 500 is DTB.

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Other records listing R.E. Brown Co., 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.

K781624PACING LEAD MODEL BUS 860, BUS 890K781625PACING LEAD MODEL MVM 860, MVM 890K781626PACING LEAD ADAPTER, ACV 14, ACV 23K781620PACING LEAD MODELS, MDM 1060, MDM 1090K781623PACING MODELS MUM 860, MUM 890K781621PACING LEAD MODELS, MAM 1260 MAM 1290

View all 10 devices →

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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