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FDA 510(k)

SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER

K-Number: K990713 · 1999-10-22

ApplicantSpectranetics Corp.
Decision Date1999-10-22
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 1999-10-22 under 510(k) number K990713. 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 SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER?

SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER is a medical device that received FDA 510(k) clearance on 1999-10-22. The listed applicant is Spectranetics Corp.. The 510(k) number is K990713.

When did SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER receive FDA 510(k) clearance?

SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER received FDA 510(k) clearance on 1999-10-22, under 510(k) number K990713.

Who is the listed applicant for SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER?

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

What is the FDA product code for SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER?

The FDA product code for SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER is DRB.

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Other records listing Spectranetics Corp. 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 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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