FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY
K Number: K863982
·
Decision Oct 24, 1986
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
13
Applicant Total
19
Review Days
10
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Basic Information
- Device Name
- VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY
- K Number
- K863982
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Vas-Cath of Canada , Ltd.
- Date Received
- October 14, 1986
- Decision Date
- October 24, 1986
- Product Code
- JCY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| JCY | Catheter, Infusion | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JCY), ordered by most recent decision date.
SILICONE SUMP DRAIN 20 & 40 FRENCH
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CHEMOTHERAPY INFUSION CATHETER
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SILICONE ELASTOMER INFUSION CATHETER
FDA 510(k)
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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 |
| 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 |
| K850009 | EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER | May 13, 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 |