FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211
K Number: K960965
·
Decision Sep 12, 1996
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
204
Applicant Total
10
Review Days
185
Basic Information
- Device Name
- FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211
- K Number
- K960965
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- COEUR LABORATORIES, INC.
- Date Received
- March 11, 1996
- Decision Date
- September 12, 1996
- Product Code
- DXT
- 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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
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| K885202 | 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR | Jan 31, 1989 | Substantially Equivalent |
| K881646 | UROLOGICAL CATHETER | Jun 16, 1988 | Substantially Equivalent |
| K874579 | COEUR CONTROL SYRINGE | Jan 19, 1988 | Substantially Equivalent |
| K873597 | TUBING, POLYETHYLENE | Nov 12, 1987 | Substantially Equivalent |
| K823920 | COEURLOCK STERILE DISPOS. ANGIOGRAPHIC | Feb 18, 1983 | Substantially Equivalent |