FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER
K Number: K850009
·
Decision May 13, 1985
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
74
Applicant Total
19
Review Days
131
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Basic Information
- Device Name
- EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER
- K Number
- K850009
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Vas-Cath of Canada , Ltd.
- Date Received
- January 2, 1985
- Decision Date
- May 13, 1985
- Product Code
- BSO
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSO | Catheter, Conduction, Anesthetic | FDA class 2 | Anesthesiology |
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Other Clearances by Vas-Cath of Canada , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K875188 | LUER LOCK CONNECTORS / RIDIG P.V.C. | Mar 2, 1988 | Substantially Equivalent |
| K871817 | VAS-CATH PERITONEAL DIALYSIS CATHETER | Jul 16, 1987 | Substantially Equivalent |
| K871488 | VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH | Jun 12, 1987 | Substantially Equivalent |
| K871487 | VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH | Jun 12, 1987 | Substantially Equivalent |
| K863982 | VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY | Oct 24, 1986 | Substantially Equivalent |
| K853283 | VACCESS TM 4006 | Aug 22, 1985 | Substantially Equivalent |
| K844854 | OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT | May 21, 1985 | Substantially Equivalent |
| K844800 | OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS | May 16, 1985 | Substantially Equivalent |
| K844336 | VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH | Mar 13, 1985 | Substantially Equivalent |
| K844433 | VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA | Mar 13, 1985 | Substantially Equivalent |