FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED COMPRESSION SLEEVES
K Number: K100909
·
Decision Jul 23, 2010
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
21
Review Days
113
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Basic Information
- Device Name
- REPROCESSED COMPRESSION SLEEVES
- K Number
- K100909
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ascent Healthcare Solutions
- Date Received
- April 1, 2010
- Decision Date
- July 23, 2010
- 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 Ascent Healthcare Solutions
| K Number | Device Name | ||
|---|---|---|---|
| K111600 | REPROCESSED HAND ACTIVATE SEALER/DIVIDER | Nov 15, 2011 | Substantially Equivalent |
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| K100254 | REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER | May 28, 2010 | Substantially Equivalent |
| K100537 | REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE | May 12, 2010 | Substantially Equivalent |
| K100080 | REPROCESSED TROCARS, MODEL B5LT AND CB5LT | Mar 19, 2010 | Substantially Equivalent |
| K093702 | REPROCESSED ULTRASONIC COAGULATING SHEARS | Mar 4, 2010 | Substantially Equivalent |
| K092425 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 | Oct 21, 2009 | Substantially Equivalent |
| K090323 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Apr 1, 2009 | Substantially Equivalent |
| K082023 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Sep 16, 2008 | Substantially Equivalent |
| K081238 | REPROCESSED MASIMO PULSE OXIMETER SENSORS | Jul 29, 2008 | Substantially Equivalent |