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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Spectranetics Corp. — Predicate Candidate Screening

24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
232 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140047LEXICONTURE MECHANICAL DILATOR SHEATH SETSpectranetics Corp.2014-04-09900
K1236322.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035Spectranetics Corp.2013-01-25631
K1120328FR TURBO - TANDEM SYSTEMSpectranetics Corp.2011-10-17940
K093257TORQMAX SHEATH GRIP ACCESSORYSpectranetics Corp.2010-03-261580
K094036TURBO-TANDEM SYSTEM MODEL 472-110Spectranetics Corp.2010-01-25260
K092378SPECTRANETICS VISISHEATH DILATOR SHEATHSpectranetics Corp.2009-11-02890
K092396SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERSSpectranetics Corp.2009-09-04300
K091299SPECTRANETICS TURBO-TANDEM SYSTEMSpectranetics Corp.2009-07-01580
K090913CROSS-PILOT TURBO ELITE SUPPORT CATHETERSpectranetics Corp.2009-05-04330
K082559SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETERSpectranetics Corp.2008-12-11980
K082561SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERSSpectranetics Corp.2008-12-10970
K072750SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065Spectranetics Corp.2007-12-04680
K071227CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4Spectranetics Corp.2007-07-11691
K0712268FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL Spectranetics Corp.2007-06-29572
K060012CLIRPATH TURBO PERIPHERAL CATHETERSSpectranetics Corp.2006-09-292690
K052514CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151,Spectranetics Corp.2005-10-19350
K052296CLIRPATH TURBO EXCIMER LASER CATHETERSSpectranetics Corp.2005-09-02100
K0434652.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011Spectranetics Corp.2005-08-182460
K043401SPECTRANETICS LLD CS, MODEL 518-039Spectranetics Corp.2005-03-16960
K040067CLIRPATH EXCIMER LASER CATHETERSpectranetics Corp.2004-04-271040
K033678SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033Spectranetics Corp.2004-02-23910
K022138SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028Spectranetics Corp.2002-09-23830
K991059SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRASpectranetics Corp.1999-11-162310
K990713SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTERSpectranetics Corp.1999-10-222320

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda