FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
D-Stat Radial Topical Hemostat
K Number: K200720
·
Decision Jun 26, 2020
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
17
Applicant Total
11
Review Days
99
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Basic Information
- Device Name
- D-Stat Radial Topical Hemostat
- K Number
- K200720
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vascular Solutions, LLC
- Date Received
- March 19, 2020
- Decision Date
- June 26, 2020
- 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 DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER
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
Other Clearances by Vascular Solutions, LLC
| K Number | Device Name | ||
|---|---|---|---|
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| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter | Feb 9, 2022 | Substantially Equivalent |
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| K193119 | Twin-Pass Dual Access Catheter | Jun 29, 2020 | Substantially Equivalent |
| K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | Aug 9, 2019 | Substantially Equivalent |
| K182570 | Venture 0.014 Catheter | Mar 13, 2019 | Substantially Equivalent |