FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018
K Number: K162350
·
Decision Nov 4, 2016
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
231
Review Days
73
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018
- K Number
- K162350
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- August 23, 2016
- Decision Date
- November 4, 2016
- Product Code
- LIT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIT), ordered by most recent decision date.
WAVE PTA Balloon Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Armada 14 NC PTA Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amethyst HP PTA OTW 0.035 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amethyst HP PTA OTW 0.035 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Boston Scientific Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K260428 | RIVOS EUS Access Device (M00553900) | Jun 17, 2026 | Substantially Equivalent |
| K260100 | MOSES Raydar | May 18, 2026 | Substantially Equivalent |
| K260771 | TruSelect 2.6 Microcatheter | May 15, 2026 | Substantially Equivalent |
| K251273 | Asurys Fluid Management System | Mar 27, 2026 | Substantially Equivalent |
| K260479 | TheraSphere 360 Y-90 Management Platform | Mar 13, 2026 | Substantially Equivalent |
| K260119 | SpaceOAR Vue System (SV-2101) | Feb 10, 2026 | Substantially Equivalent |
| K252529 | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120) | Oct 30, 2025 | Substantially Equivalent |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010) | Oct 30, 2025 | Substantially Equivalent |
| K252547 | TheraSphere 360 Y-90 Management Platform | Oct 28, 2025 | Substantially Equivalent |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Sep 26, 2025 | Substantially Equivalent |