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FDA 510(k)

MAGELLAN

K-Number: K961903 · 1998-08-24

ApplicantBiosense, Ltd.
Decision Date1998-08-24
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAGELLAN is the device name listed in this FDA 510(k) record. The listed applicant is Biosense, Ltd.. It received FDA 510(k) clearance on 1998-08-24 under 510(k) number K961903. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGELLAN?

MAGELLAN is a medical device that received FDA 510(k) clearance on 1998-08-24. The listed applicant is Biosense, Ltd.. The 510(k) number is K961903.

When did MAGELLAN receive FDA 510(k) clearance?

MAGELLAN received FDA 510(k) clearance on 1998-08-24, under 510(k) number K961903.

Who is the listed applicant for MAGELLAN?

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

What is the FDA product code for MAGELLAN?

The FDA product code for MAGELLAN is HAW.

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 Biosense, Ltd. 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.

K960542NOGAK954395CARTO SYSTEM

Related Devices (Code: HAW)

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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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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