FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER
K Number: K102212
·
Decision Apr 8, 2011
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
17
Applicant Total
87
Review Days
245
Basic Information
- Device Name
- D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER
- K Number
- K102212
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VASCULAR SOLUTIONS, INC.
- Date Received
- August 6, 2010
- Decision Date
- April 8, 2011
- Product Code
- QSX
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| QSX | Hemostatic Wound Dressing With Thrombin Or Other Biologics | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QSX), ordered by most recent decision date.
D-Stat Radial Topical Hemostat
FDA 510(k)
FDA Unclassified
·Unknown
D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505
FDA 510(k)
FDA Unclassified
·Unknown
D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015
FDA 510(k)
FDA Unclassified
·Unknown
D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005
FDA 510(k)
FDA Unclassified
·Unknown
THROMBIX PATCH THROMBIN HEMOSTASIS PATCH
FDA 510(k)
FDA Unclassified
·Unknown
THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT
FDA 510(k)
FDA Unclassified
·Unknown
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|---|---|---|---|
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| K152387 | Fluent Inflation Device | Dec 18, 2015 | Unknown |
| K151234 | R350 guidewire | Nov 18, 2015 | Substantially Equivalent |
| K142065 | TURNPIKE CATHETER | Nov 25, 2014 | Substantially Equivalent |
| K143038 | Gel-Block 10X embolization pledgets | Nov 20, 2014 | Substantially Equivalent |
| K133237 | GEL-BEAD EMBOLIZATION SPHERES | Apr 25, 2014 | Substantially Equivalent |
| K132789 | FLIP INTRODUCER ACCESS KIT | Apr 17, 2014 | Substantially Equivalent |
| K133501 | LEADLINER CS LEAD DELIVERY SYSTEM | Feb 25, 2014 | Substantially Equivalent |