FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SITERITE NEEDLE GUIDE
K Number: K903158
·
Decision Sep 27, 1990
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
7
Review Days
71
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Basic Information
- Device Name
- SITERITE NEEDLE GUIDE
- K Number
- K903158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Dymax Corp
- Date Received
- July 18, 1990
- Decision Date
- September 27, 1990
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Dymax Corp
| K Number | Device Name | ||
|---|---|---|---|
| K032135 | SITE-RITE IV ULTRASOUND SYSTEM | Jul 21, 2003 | Substantially Equivalent |
| K993624 | SITE-RITE 3 ULTRASOUND SYSTEM | Nov 10, 1999 | Substantially Equivalent |
| K931403 | SITERITE NEEDLE GUIDE (MODIFIED) | Jul 27, 1993 | Substantially Equivalent |
| K894415 | DYMAX ENDOVAGINAL BIOPSY GUIDE | Oct 25, 1989 | Substantially Equivalent |
| K862127 | DYMAX PERSONAL SCANNER | Dec 11, 1986 | Substantially Equivalent |
| K850478 | PLUS 1 | Apr 15, 1985 | Substantially Equivalent |