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FDA 510(k)

MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151

K-Number: K080924 · 2008-04-30

ApplicantSt. Jude Medical, Cardiac Rhythm Management Divisi
Decision Date2008-04-30
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Cardiac Rhythm Management Divisi. It received FDA 510(k) clearance on 2008-04-30 under 510(k) number K080924. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151?

MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 is a medical device that received FDA 510(k) clearance on 2008-04-30. The listed applicant is St. Jude Medical, Cardiac Rhythm Management Divisi. The 510(k) number is K080924.

When did MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 receive FDA 510(k) clearance?

MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 received FDA 510(k) clearance on 2008-04-30, under 510(k) number K080924.

Who is the listed applicant for MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151?

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

What is the FDA product code for MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151?

The FDA product code for MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 is DRB.

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Other records listing St. Jude Medical, Cardiac Rhythm Management Divisi as applicant

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Related Devices (Code: DRB)

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.

K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)K191469Biotronik StyletsBiotronik, Inc.K182660GaltTWSGalt Medical Corp.K170298Liberator Beacon Tip Locking StyletCook IncorporatedK090163STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078St Jude MedicalK072864ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEMSt. Jude Medical, Cardiac Rhythm Management Divisi

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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