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FDA 510(k)

NAVIGATOR

K-Number: K853747 · 1986-01-08

ApplicantMainsfield Scientific, Inc.
Decision Date1986-01-08
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NAVIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mainsfield Scientific, Inc.. It received FDA 510(k) clearance on 1986-01-08 under 510(k) number K853747. 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 NAVIGATOR?

NAVIGATOR is a medical device that received FDA 510(k) clearance on 1986-01-08. The listed applicant is Mainsfield Scientific, Inc.. The 510(k) number is K853747.

When did NAVIGATOR receive FDA 510(k) clearance?

NAVIGATOR received FDA 510(k) clearance on 1986-01-08, under 510(k) number K853747.

Who is the listed applicant for NAVIGATOR?

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

What is the FDA product code for NAVIGATOR?

The FDA product code for NAVIGATOR is DTB.

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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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