FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS
K Number: K011487
·
Decision Nov 21, 2001
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
89
Applicant Total
12
Review Days
190
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Basic Information
- Device Name
- CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS
- K Number
- K011487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Somanetics Corp.
- Date Received
- May 15, 2001
- Decision Date
- November 21, 2001
- Product Code
- DXZ
- 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 |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | FDA class 2 | Cardiovascular |
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Other Clearances by Somanetics Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K091224 | OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S | Jul 9, 2009 | Substantially Equivalent |
| K082327 | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C | Apr 3, 2009 | Substantially Equivalent |
| K080769 | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C | May 14, 2008 | Substantially Equivalent |
| K051274 | INVOS SYSTEM | Nov 4, 2005 | Substantially Equivalent |
| K040162 | CORRESTORE PATCH SYSTEM | Mar 16, 2004 | Substantially Equivalent |
| K031586 | CORRESTORE PATCH SYSTEM | Aug 7, 2003 | Substantially Equivalent |
| K001842 | ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 | Sep 15, 2000 | Substantially Equivalent |
| K971628 | SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) | Oct 10, 1997 | Substantially Equivalent |
| K960614 | SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) | Jun 5, 1996 | Substantially Equivalent |