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FDA 510(k)

MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180

K-Number: K101982 · 2010-12-21

ApplicantSt Jude Medical, Crmd
Decision Date2010-12-21
Product CodeDTA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical, Crmd. It received FDA 510(k) clearance on 2010-12-21 under 510(k) number K101982. The device is classified under product code DTA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180?

MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 is a medical device that received FDA 510(k) clearance on 2010-12-21. The listed applicant is St Jude Medical, Crmd. The 510(k) number is K101982.

When did MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 receive FDA 510(k) clearance?

MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 received FDA 510(k) clearance on 2010-12-21, under 510(k) number K101982.

Who is the listed applicant for MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180?

The FDA 510(k) record lists St Jude Medical, Crmd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180?

The FDA product code for MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 is DTA.

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Related Devices (Code: DTA)

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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