FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO SECURACATH, MODEL: SPK01
K Number: K083081
·
Decision Mar 4, 2009
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
7
Review Days
139
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODIFICATION TO SECURACATH, MODEL: SPK01
- K Number
- K083081
- 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
- October 16, 2008
- Decision Date
- March 4, 2009
- Product Code
- OKC
- 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 |
|---|---|---|---|
| OKC | Implanted Subcutaneous Securement Catheter | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OKC), ordered by most recent decision date.
SecurAcath
FDA 510(k)
FDA Class 2
·General Hospital
SecurAcath
FDA 510(k)
FDA Class 2
·General Hospital
SECURACATH
FDA 510(k)
FDA Class 2
·General Hospital
SECURACATH CATHETER, MODEL SPK01
FDA 510(k)
FDA Class 2
·General Hospital
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 |
| K092306 | SECURACATH UNIVERSAL | Jul 9, 2010 | Substantially Equivalent |
| K082047 | SECURACATH CATHETER, MODEL SPK01 | Sep 30, 2008 | Substantially Equivalent |