FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K Number: K033721
·
Decision Feb 13, 2004
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
103
Review Days
79
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
- VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
- K Number
- K033721
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vascular Solutions, Inc.
- Date Received
- November 26, 2003
- Decision Date
- February 13, 2004
- Product Code
- FMF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMF), ordered by most recent decision date.
Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
FDA 510(k)
FDA Class 2
·General Hospital
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
FDA 510(k)
FDA Class 2
·General Hospital
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
FDA 510(k)
FDA Class 2
·General Hospital
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Instylla Delivery Kit
FDA 510(k)
FDA Class 2
·General Hospital
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 |