FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LLD EZ
K Number: K142116
·
Decision Aug 12, 2014
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
27
Applicant Total
17
Review Days
8
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
- LLD EZ
- K Number
- K142116
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Spectranetics, Inc.
- Date Received
- August 4, 2014
- Decision Date
- August 12, 2014
- Product Code
- DRB
- 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 |
|---|---|---|---|
| DRB | Stylet, Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRB), ordered by most recent decision date.
Arrow Stiffening Stylet
FDA 510(k)
FDA Class 2
·Cardiovascular
Biotronik Stylets
FDA 510(k)
FDA Class 2
·Cardiovascular
GaltTWS
FDA 510(k)
FDA Class 2
·Cardiovascular
Liberator Beacon Tip Locking Stylet
FDA 510(k)
FDA Class 2
·Cardiovascular
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
FDA 510(k)
FDA Class 2
·Cardiovascular
MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Spectranetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 | Substantially Equivalent |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Dec 8, 2022 | Substantially Equivalent |
| K212784 | TightRail Guardian Motorized Dilator Sheath | Aug 24, 2022 | Substantially Equivalent |
| DEN210024 | CavaClear Laser Sheath | Dec 21, 2021 | Unknown |
| K203540 | Bridge Occlusion Balloon | Dec 23, 2020 | Substantially Equivalent |
| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Apr 5, 2018 | Substantially Equivalent |
| K172687 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Nov 27, 2017 | Substantially Equivalent |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters | Apr 7, 2017 | Substantially Equivalent |
| K162561 | Turbo-Power (2.0mm) Laser Atherectomy Catheters | Jan 5, 2017 | Substantially Equivalent |
| K161333 | TightRail Sub-C Rotating Dilator Sheath | Jul 8, 2016 | Substantially Equivalent |