FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
K Number: K100518
·
Decision Aug 31, 2010
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
19
Applicant Total
7
Review Days
189
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Basic Information
- Device Name
- INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
- K Number
- K100518
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4475
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumed International, Inc.
- Date Received
- February 23, 2010
- Decision Date
- August 31, 2010
- Product Code
- DWP
- 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 |
|---|---|---|---|
| DWP | Dilator, Vessel, Surgical | FDA class 2 | Cardiovascular |
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Other Clearances by Instrumed International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100517 | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | Apr 29, 2010 | Substantially Equivalent |
| K092840 | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL | Dec 3, 2009 | Substantially Equivalent |
| K092544 | INSTRUMED VASCULAR CLAMPS | Oct 26, 2009 | Substantially Equivalent |
| K081651 | INSTRUMED RONGEUR | Aug 8, 2008 | Substantially Equivalent |
| K071771 | INSTRUMED RETRACTORS | Aug 2, 2007 | Substantially Equivalent |
| K040855 | INSTRUMED LAPAROSCOPE AND ACCESSORIES | Apr 16, 2004 | Substantially Equivalent |