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FDA 510(k)

LEAD STYLET

K-Number: K905674 · 1991-01-30

ApplicantCardiac Pacemakers, Inc.
Decision Date1991-01-30
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEAD STYLET is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pacemakers, Inc.. It received FDA 510(k) clearance on 1991-01-30 under 510(k) number K905674. 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 LEAD STYLET?

LEAD STYLET is a medical device that received FDA 510(k) clearance on 1991-01-30. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K905674.

When did LEAD STYLET receive FDA 510(k) clearance?

LEAD STYLET received FDA 510(k) clearance on 1991-01-30, under 510(k) number K905674.

Who is the listed applicant for LEAD STYLET?

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

What is the FDA product code for LEAD STYLET?

The FDA product code for LEAD STYLET is DRB.

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Other records listing Cardiac Pacemakers, 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.

K093969ACUITY BREAK-AWAY GUIDE CATHETERK080154ACUITY UNIVERSAL CUTTERK934727REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELERK920601ASTRA T2, ASTRA T4, ASTRA T6K912379PDT CARRYALL TRANSMITTER, VARIOUS MODELSK900498MODIFIED BETATRON IV INSULIN INFUSION SYSTEM

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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 MedicalK080924MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151St. 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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