FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOX PLUS PTA CATHETER
K Number: K040954
·
Decision May 11, 2004
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
6
Review Days
28
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Basic Information
- Device Name
- FOX PLUS PTA CATHETER
- K Number
- K040954
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories, Inc.
- Date Received
- April 13, 2004
- Decision Date
- May 11, 2004
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
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| K061193 | CREATININE | Jun 23, 2006 | Substantially Equivalent |
| K051213 | PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS | May 27, 2005 | Substantially Equivalent |
| K040761 | AXSYM CYCLOSPORINE | Apr 30, 2004 | Substantially Equivalent |
| K023062 | GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT | Sep 30, 2002 | Substantially Equivalent |