FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPASS COMPRESSION ASSIST HANDLE
K Number: K053398
·
Decision Mar 10, 2006
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
1
Review Days
94
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
- COMPASS COMPRESSION ASSIST HANDLE
- K Number
- K053398
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Semler Technologies, Inc. Dba
- Date Received
- December 6, 2005
- Decision Date
- March 10, 2006
- Product Code
- DXC
- 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXC), ordered by most recent decision date.
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
FDA 510(k)
FDA Class 2
·Cardiovascular
Arc Adjustable Radial Cuff Compression Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Life Saving Tourniquet
FDA 510(k)
FDA Class 2
·Cardiovascular
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
FDA 510(k)
FDA Class 2
·Cardiovascular
Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
FDA 510(k)
FDA Class 2
·Cardiovascular
Radial Compression Device
FDA 510(k)
FDA Class 2
·Cardiovascular