FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT
K Number: K012621
·
Decision Feb 6, 2002
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
14
Review Days
177
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Basic Information
- Device Name
- CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT
- K Number
- K012621
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clearmedical, Inc.
- Date Received
- August 13, 2001
- Decision Date
- February 6, 2002
- Product Code
- JOW
- 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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Other Clearances by Clearmedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K033578 | REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS | Jul 11, 2005 | Substantially Equivalent |
| K033579 | REPROCESSED MULTIPLE CLIP APPLIERS | Jul 11, 2005 | Substantially Equivalent |
| K033591 | REPROCESSED TROCARS | Jun 3, 2005 | Substantially Equivalent |
| K033592 | REPROCESSED SURGICAL SCISSORS AND GRASPERS | Jul 27, 2004 | Substantially Equivalent |
| K033593 | REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS | Nov 20, 2003 | Substantially Equivalent |
| K031416 | CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF | Jul 15, 2003 | Substantially Equivalent |
| K012600 | CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L | Jul 3, 2002 | Substantially Equivalent |
| K012622 | CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 | Jul 3, 2002 | Substantially Equivalent |
| K012609 | CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 | Jul 3, 2002 | Substantially Equivalent |
| K012601 | CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH | Feb 6, 2002 | Substantially Equivalent |