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FDA 510(k)

SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028

K-Number: K022138 · 2002-09-23

ApplicantSpectranetics Corp.
Decision Date2002-09-23
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 2002-09-23 under 510(k) number K022138. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028?

SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 is a medical device that received FDA 510(k) clearance on 2002-09-23. The listed applicant is Spectranetics Corp.. The 510(k) number is K022138.

When did SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 receive FDA 510(k) clearance?

SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 received FDA 510(k) clearance on 2002-09-23, under 510(k) number K022138.

Who is the listed applicant for SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028?

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 0.035 SUPPORT CATHETER, MODEL 518-028?

The FDA product code for SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 is DQY.

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Other records listing Spectranetics Corp. as applicant

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K1236322.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035K1120328FR TURBO - TANDEM SYSTEMK093257TORQMAX SHEATH GRIP ACCESSORYK094036TURBO-TANDEM SYSTEM MODEL 472-110K092378SPECTRANETICS VISISHEATH DILATOR SHEATHK092396SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS

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Related Devices (Code: DQY)

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

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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