FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED TARGET THERAPEUTICS COILS
K Number: K901721
·
Decision Jul 3, 1990
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
179
Applicant Total
70
Review Days
81
Basic Information
- Device Name
- MODIFIED TARGET THERAPEUTICS COILS
- K Number
- K901721
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- TARGET THERAPEUTICS
- Date Received
- April 13, 1990
- Decision Date
- July 3, 1990
- Product Code
- HCG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | FDA class 2 | Neurology |
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Other Clearances by TARGET THERAPEUTICS
| K Number | Device Name | ||
|---|---|---|---|
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| K965189 | SPINNAKER | Mar 24, 1997 | Substantially Equivalent |
| K964112 | BERENSTEIN COIL | Feb 26, 1997 | Substantially Equivalent |
| K963307 | GDC PATIENT RETURN ELECTTRODE MODEL 45021 | Dec 17, 1996 | Substantially Equivalent |
| K962503 | GUGLIELMI DETACHABLE COIL | Sep 20, 1996 | Substantially Equivalent |
| K961923 | BERENSTEIN COIL | Aug 15, 1996 | Substantially Equivalent |
| K960705 | GUGLIELMI DETACHABLE COIL | May 21, 1996 | Substantially Equivalent |