FDA Registration
Active
🇺🇸 United States
SPECTRANETICS CORP.
Reg #: 3007284006
·
FEI: 3007284006
·
Expires 2026
Products
12
Proprietary Names
41
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- SPECTRANETICS CORP.
- Registration Number
- 3007284006
- FEI Number
- 3007284006
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9965 Federal Drive
- City
- Colorado Springs
- State
- CO
- ZIP
- 80921
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142116
- PMA Number
- P960042
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 2939520
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stylet, Catheter | DRB | Class 2 | Cardiovascular | No | 2018-11-26 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2022-05-16 |
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2019-10-09 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2019-09-26 |
| Catheter For Crossing Total Occlusions | PDU | Class 2 | Cardiovascular | No | 2018-11-26 |
| Catheter Introducer Kit | OFC | Class 2 | Cardiovascular | No | 2018-11-26 |
| Device, Removal, Pacemaker Electrode, Percutaneous | MFA | Class 3 | Unknown | No | 2018-11-26 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2018-11-26 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2019-03-15 |
| Device, Angioplasty, Laser, Coronary | LPC | Class 3 | Unknown | No | 2018-11-26 |
| Laser-Powered Inferior Vena Cava Filter Retrieval Catheter | QRJ | Class 2 | Cardiovascular | No | 2022-02-23 |
| Aspiration Thrombectomy Catheter | QEZ | Class 2 | Cardiovascular | No | 2018-11-26 |
Proprietary Names
LLD EZ Lead Locking Device
Bridge Occlusion Balloon
Turbo-Elite Laser Atherectomy Catheter
Turbo-Power Laser Atherectomy Catheter
TightRail Mini Rotating Dilator Sheath
TightRail Rotating Dilator Sheath
TightRail Sub-C Rotating Dilator Sheath
Phoenix Atherectomy System 2.2mm x 149cm
Phoenix Atherectomy System 1.8mm x 149cm
Phoenix Atherectomy Catheter 1.8mm x 149cm
Phoenix Handle with Wire Support Clip
Phoenix Atherectomy Catheter 2.2mm x 149cm
Bridge Prep Kit
GlideLight Laser Sheath
Quick-Cross Support Catheter
TorqMax Sheath Grip Accessory
Phoenix Atherectomy Catheter 2.4mm x 130cm
Phoenix Atherectomy System 2.4mm x 130cm
Bridge Plus Occlusion Balloon Catheter
Phoenix Floppy Tip, Extra Support Guidewire
Phoenix Floppy Tip, Light Support Guidewire
ELCA Coronary Laser Atherectomy Catheter
CVX-300 Excimer Laser System
Philips Laser System
Phoenix Deflecting Atherectomy System 2.4mm x 127cm
CavaClear Laser Sheath
VisiSheath Dilator Sheath
QuickCat Extraction Catheter
Phoenix Pre-Deflected Atherectomy System 2.2mm x 130cm
Phoenix Pre-Deflected Atherectomy Catheter 2.2mm x 130cm
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3
Phoenix Atherectomy System 2.2mm x 130cm
Phoenix Atherectomy System 1.8mm x 130cm
Phoenix Atherectomy Catheter 2.2mm x 130cm
Phoenix Atherectomy Catheter 1.8mm x 130cm
LLD E Lead Locking Device
Phoenix Pre-Deflected Atherectomy System 2.4mm x 130cm
Phoenix Atherectomy System 1.5mm x 149cm
Phoenix Pre-Deflected Atherectomy Catheter 2.4mm x 130cm
Phoenix Atherectomy Catheter 1.5mm x 149cm
Quick-Cross Extreme Support Catheters and Quick-Cross Select Support Catheters
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility