FDA 510(k)
FDA unclassified
Substantially Equivalent
🇸🇪 Sweden
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K Number: K033291
·
Decision Mar 17, 2004
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
126
Applicant Total
24
Review Days
155
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Basic Information
- Device Name
- TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
- K Number
- K033291
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radi Medical Systems AB
- Date Received
- October 14, 2003
- Decision Date
- March 17, 2004
- Product Code
- QSY
- 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 |
|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | FDA unclassified | Unknown |
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| K080206 | MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM | Feb 26, 2008 | Substantially Equivalent |
| K062769 | PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 | Dec 4, 2006 | Substantially Equivalent |
| K042628 | MODIFICATION TO: RADIANALYZER, MODEL 12711 | Jan 19, 2005 | Substantially Equivalent |
| K031662 | PRESSURE WIRE SENSOR, MODELS 12004/12304 | Jun 6, 2003 | Substantially Equivalent |
| K024107 | FEMOSTOP FEMORAL COMPRESSION SYSTEM | Dec 24, 2002 | Substantially Equivalent |
| K022188 | RADIANALYZER, MODEL 12710 | Oct 3, 2002 | Substantially Equivalent |
| K022187 | PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 | Sep 24, 2002 | Substantially Equivalent |