FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER ANTIMIC CATHETER
K Number: K072702
·
Decision Mar 19, 2008
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
74
Applicant Total
6
Review Days
177
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Basic Information
- Device Name
- STRYKER ANTIMIC CATHETER
- K Number
- K072702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Instruments, Instruments Div.
- Date Received
- September 24, 2007
- Decision Date
- March 19, 2008
- Product Code
- BSO
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSO | Catheter, Conduction, Anesthetic | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K123178 | STRYKER VENOM ELECTRODES AND CANNULAE | Mar 28, 2013 | Substantially Equivalent |
| K113477 | IVAS 20MM (10 GAUGE) BALLOON CATHETER | Jan 6, 2012 | Substantially Equivalent |
| K093419 | IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS | Mar 18, 2010 | Substantially Equivalent |
| K073017 | STRYKER STRI-SHIELD FLYTE TOGAS | Nov 30, 2007 | Substantially Equivalent |
| K070078 | STRYKER T4 HYTREL TOGA | Feb 2, 2007 | Substantially Equivalent |