Spectranetics LLD CS, Model 518-039
FDA 510(k) K043401 · Spectranetics Corp.
510(k) numberK043401
Submission
- Device name
- Spectranetics LLD CS, Model 518-039
- Applicant
- Spectranetics Corp.
Colorado Springs, CO, US - Received
- December 10, 2004
- Decision date
- March 16, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRB – Stylet, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1380
- Specialty
- Cardiovascular
Other 510(k)s with product code DRB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220280 | Arrow Stiffening StyletDRB · Traditional | Arrow International, LLC (A subsidiary of… | 08/30/2022SE |
| K191469 | Biotronik StyletsDRB · Traditional | Biotronik, Inc. | 08/01/2019SE |
| K182660 | GaltTWSDRB · Traditional | Galt Medical Corp. | 05/30/2019SE |
| K170298 | Liberator Beacon Tip Locking StyletDRB · Traditional | Cook Incorporated | 10/18/2017SE |
| K142116 | LLD EzDRB · Special | Spectranetics, Inc. | 08/12/2014SE |
| K090163 | Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078DRB · Traditional | St Jude Medical | 04/01/2009SE |
| K080924 | Mond Rvot Stylet Models 4140, 4141, 4150, 4151DRB · Traditional | St. Jude Medical, Cardiac Rhythm Management Divisi | 04/30/2008SE |
| K072864 | St. Jude Medical, CPS Duo Left Heart Lead Delivery SystemDRB · Traditional | St. Jude Medical, Cardiac Rhythm Management Divisi | 03/13/2008SE |
| K053019 | Acuity Steerable Stylet AccessoryDRB · Traditional | Guidant Corporation | 03/03/2006SE |
| K052965 | Easytrak 2 Stylet, Models 4826, 4829, 4832.DRB · Traditional | Guidant Corporation | 02/13/2006SE |
More from Guidant Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K250385 | Turbo-Elite Laser Atherectomy CatheterMCW · Special | 03/13/2025SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | 12/15/2022SE |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Special | 12/08/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | 08/24/2022SE |
| K203540 | Bridge Occlusion BalloonMJN · Special | 12/23/2020SE |
| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Special | 04/05/2018SE |
| K172687 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Traditional | 11/27/2017SE |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy CathetersMCW · Traditional | 04/07/2017SE |
| K162561 | Turbo-Power (2.0mm) Laser Atherectomy CathetersMCW · Traditional | 01/05/2017SE |
| K161333 | TightRail Sub-C Rotating Dilator SheathDRE · Traditional | 07/08/2016SE |
Questions and answers
When was Spectranetics LLD CS, Model 518-039 cleared by the FDA?
Spectranetics LLD CS, Model 518-039 (K043401) received a 510(k) decision of Substantially Equivalent on March 16, 2005, 96 days after the submission was received.
What is the product code of K043401?
The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.