# Spectranetics Corp.

- Location (FDA's records): Colorado Springs, CO
- FDA decisions: 48 (1992–2025): 43 510(k) clearances, 1 De Novo grant and 4 original PMA approvals
- Names in FDA's records: Spectranetics Corp. (27); Spectranetics, Inc. (17); Spectranetics Corporation (2); Spectranetics (1); The Spectranetics Corp. (1)
- Product codes: DQY (11), MCW (10), DRE (9), PDU (7), DRB (3), MJN (2), LPC (2), OFC (1), QRJ (1), ONU (1), NWX (1)
- 510(k) review time since 2016: median 58 days, against 91 for FDA's reviews in the same codes and years (7 of 11 faster)
- Predicates its devices cite: 67 (51 its own); citations of its devices by later devices: 90 (51 its own)
- Recalls linked to its devices: 15 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Terumo Medical Corp.: 2 (https://510kreport.com/company/terumo-medical)
- Medtronics Interventional Vascular: 2 (https://510kreport.com/company/medtronics-interventional-vascular)
- Heart Technology, Inc.: 2 (https://510kreport.com/company/heart-technology)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)
- Cook Vascular, Inc.: 1 (https://510kreport.com/company/cook-vascular)
- Cook Pacemaker Corp.: 1 (https://510kreport.com/company/cook-pacemaker)
- Intra Luminal Therapeutics, Inc.: 1 (https://510kreport.com/company/intra-luminal-therapeutics)

## Firms that cite its devices most
- Vascular Solutions, Inc.: 5 (https://510kreport.com/company/vascular-solutions)
- Terumo Medical Corp.: 3 (https://510kreport.com/company/terumo-medical)
- Medtronic Vascular: 3 (https://510kreport.com/company/medtronic-vascular)
- Reflow Medical, Inc.: 3 (https://510kreport.com/company/reflow-medical)
- Tractus Vascular, LLC: 2 (https://510kreport.com/company/tractus-vascular)
- Qxmedical, LLC: 2 (https://510kreport.com/company/qxmedical)
- Upstream Peripheral Technologies: 2 (https://510kreport.com/company/upstream-peripheral-technologies)
- Transit Scientific, LLC: 2 (https://510kreport.com/company/transit-scientific)

## Its most-cited devices
- K033678: Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 and 518-038 (2004), cited by 9
- K072750: Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 (2007), cited by 8
- K991059: Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support Catheter, Model 518-017 (1999), cited by 7
- K082561: Spectranetics Quick-Cross Extreme Support Catheters (2008), cited by 6
- K092396: Spectranetics Quick Cross Extreme Support Catheters (2009), cited by 6
- K022138: Spectranetics 0.035 Support Catheter, Model 518-028 (2002), cited by 5

## Recent decisions
- K250385: Turbo-Elite Laser Atherectomy Catheter (Mar 13, 2025)
- K223472: TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) (Dec 15, 2022)
- K222837: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (Dec 8, 2022)
- K212784: TightRail Guardian Motorized Dilator Sheath (Aug 24, 2022)
- DEN210024: CavaClear Laser Sheath (Dec 21, 2021)
- K203540: Bridge Occlusion Balloon (Dec 23, 2020)
- K180694: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (Apr 5, 2018)
- K172687: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (Nov 27, 2017)

Source page: https://510kreport.com/company/spectranetics