FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AXIOM TROCAR THORACIC CATHETER
K Number: K863247
·
Decision Aug 29, 1986
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
26
Applicant Total
28
Review Days
7
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Basic Information
- Device Name
- AXIOM TROCAR THORACIC CATHETER
- K Number
- K863247
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Axiom Medical, Inc.
- Date Received
- August 22, 1986
- Decision Date
- August 29, 1986
- Product Code
- GBS
- 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 |
|---|---|---|---|
| GBS | Catheter, Ventricular, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBS), ordered by most recent decision date.
ATRIUMS PDR THORACIC CATHETER
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AXIOM ATRAUM WOUND DRAINS
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INTRODUCTION/DRAINAGE CATHETER & ACCESS
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URESIL WOUND DRAIN TROCAR
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NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP
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FDA Class 1
·General, Plastic Surgery
CLOSED CHEST DRAINAGE SET W/SUTURES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Axiom Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993592 | AXIOM MULTIPURPOSE WOUND DRAIN | May 17, 2000 | Substantially Equivalent |
| K971851 | INTERPLEURAL ANESTHESIA CATHETER | Jan 22, 1998 | Substantially Equivalent |
| K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR | Mar 10, 1997 | Substantially Equivalent |
| K934895 | GLASSMAN SILICONE CATHETER | Oct 13, 1994 | Substantially Equivalent |
| K922760 | ATRAUM WOUND DRESSING--MODIFICATION | Oct 30, 1992 | Substantially Equivalent |
| K905422 | PVC ROUND WOUND DRAINS | Feb 11, 1991 | Substantially Equivalent |
| K904218 | SUCTION SYSTEM | Oct 31, 1990 | Substantially Equivalent |
| K904133 | DISPOSABLE FLUID COLLECTION BAG | Oct 11, 1990 | Substantially Equivalent |
| K861306 | SUCTION SYSTEM | Jun 9, 1986 | Substantially Equivalent |
| K852614 | ATRAUM WOUND DRESSING | Aug 30, 1985 | Substantially Equivalent |