FDA 510(k)

CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001

K-Number: K052514 · 2005-10-19

Decision Date2005-10-19

Product CodePDU

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 2005-10-19 under 510(k) number K052514. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001?

CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 is a medical device that received FDA 510(k) clearance on 2005-10-19. The listed applicant is Spectranetics Corp.. The 510(k) number is K052514.

When did CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 receive FDA 510(k) clearance?

CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 received FDA 510(k) clearance on 2005-10-19, under 510(k) number K052514.

Who is the listed applicant for CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001?

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 CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001?

The FDA product code for CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 is PDU.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Spectranetics Corp. as applicant

K1236322.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 K1120328FR TURBO - TANDEM SYSTEM K093257TORQMAX SHEATH GRIP ACCESSORY K094036TURBO-TANDEM SYSTEM MODEL 472-110 K092378SPECTRANETICS VISISHEATH DILATOR SHEATH K092396SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS

View all 23 devices →

Related Devices (Code: PDU)

K262013Kiba CTO Crossing CatheterReflow Medical, Inc.K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K251376LimFlow ARCLimFlow, Inc.K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.

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.