FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEL-BLOCK EMBOLIZATION PLEDGETS
K Number: K113266
·
Decision May 14, 2012
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
128
Applicant Total
103
Review Days
192
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
- GEL-BLOCK EMBOLIZATION PLEDGETS
- K Number
- K113266
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vascular Solutions, Inc.
- Date Received
- November 4, 2011
- Decision Date
- May 14, 2012
- Product Code
- KRD
- 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 |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRD), ordered by most recent decision date.
HARBOR Occlusion Device
FDA 510(k)
FDA Class 2
·Cardiovascular
LOBO Vascular Occlusion System
FDA 510(k)
FDA Class 2
·Cardiovascular
Concerto Versa Detachable Coil
FDA 510(k)
FDA Class 2
·Cardiovascular
Tembo Embolic System
FDA 510(k)
FDA Class 2
·Cardiovascular
OBSIDIO Conformable Embolic (M0013972101010)
FDA 510(k)
FDA Class 2
·Cardiovascular
Polyvinyl Alcohol Embolic Microspheres
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Vascular Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182232 | Octane Mechanical Thrombectomy System | Sep 11, 2018 | Substantially Equivalent |
| K181647 | Bandit guidewire | Jul 20, 2018 | Substantially Equivalent |
| K180913 | VSI Micro-Introducer Kit | May 9, 2018 | Substantially Equivalent |
| K180088 | TrapLiner catheter | Apr 4, 2018 | Substantially Equivalent |
| K180128 | Warrior 14 guidewire | Feb 16, 2018 | Substantially Equivalent |
| K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume | Jan 19, 2018 | Substantially Equivalent |
| K173532 | Raider Guidewire | Dec 15, 2017 | Substantially Equivalent |
| K173266 | Octane aspiration system | Dec 1, 2017 | Substantially Equivalent |
| K170544 | Langston dual lumen catheter | Nov 17, 2017 | Substantially Equivalent |
| K171946 | Gel-Bead | Oct 25, 2017 | Substantially Equivalent |