FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ATRIUM THORACIC CATHETER
K Number: K831931
·
Decision Oct 4, 1983
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
23
Applicant Total
63
Review Days
111
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Basic Information
- Device Name
- ATRIUM THORACIC CATHETER
- K Number
- K831931
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Atrium Medical Corp.
- Date Received
- June 15, 1983
- Decision Date
- October 4, 1983
- Product Code
- GBZ
- 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 |
|---|---|---|---|
| GBZ | Catheter, Cholangiography | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBZ), ordered by most recent decision date.
PRE-VIEW CHOLANGIOGRAPHY CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDOPATH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Atrium Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130131 | EDRAIN CHEST DRAINAGE SYSTEM | Feb 28, 2013 | Substantially Equivalent |
| K122138 | ATRIUM FLIXENE IFG VASCULAR GRAFT | Aug 17, 2012 | Substantially Equivalent |
| K121070 | C-QUR RPM MESH | Apr 26, 2012 | Substantially Equivalent |
| K113112 | CLEARWAY RX NB CATHETER | Nov 17, 2011 | Substantially Equivalent |
| K102596 | ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT | Oct 5, 2010 | Substantially Equivalent |
| K093431 | CLEARWAY OTW MODEL 85912 | Apr 20, 2010 | Substantially Equivalent |
| K100076 | ATRIUM C-QUR OVT MESH | Jan 26, 2010 | Substantially Equivalent |
| K090909 | C-QUR V -PATCH MESH | Jun 4, 2009 | Substantially Equivalent |
| K082748 | ATRIUM PROLITE S MESH | Jan 14, 2009 | Substantially Equivalent |
| K081718 | EXPRESS CHEST DRAIN | Jul 25, 2008 | Substantially Equivalent |