FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SECURACATH UNIVERSAL
K Number: K092306
·
Decision Jul 9, 2010
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
301
Applicant Total
7
Review Days
345
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Basic Information
- Device Name
- SECURACATH UNIVERSAL
- K Number
- K092306
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Interrad Medical, Inc.
- Date Received
- July 29, 2009
- Decision Date
- July 9, 2010
- Product Code
- LJS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by Interrad Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K210629 | SecurAcath | Apr 12, 2021 | Substantially Equivalent |
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F | Jul 9, 2019 | Substantially Equivalent |
| K180769 | SecurAcath | Jun 26, 2018 | Substantially Equivalent |
| K120935 | SECURACATH | Apr 27, 2012 | Substantially Equivalent |
| K083081 | MODIFICATION TO SECURACATH, MODEL: SPK01 | Mar 4, 2009 | Substantially Equivalent |
| K082047 | SECURACATH CATHETER, MODEL SPK01 | Sep 30, 2008 | Substantially Equivalent |