FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXPRESS CHEST DRAIN
K Number: K081718
·
Decision Jul 25, 2008
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
47
Applicant Total
63
Review Days
37
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EXPRESS CHEST DRAIN
- K Number
- K081718
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Atrium Medical Corp.
- Date Received
- June 18, 2008
- Decision Date
- July 25, 2008
- Product Code
- KDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDQ), ordered by most recent decision date.
MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
OCEAN CHEST DRAIN
FDA 510(k)
FDA Class 2
·General Hospital
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
FDA 510(k)
FDA Class 2
·General Hospital
PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
FDA 510(k)
FDA Class 2
·General Hospital
ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
MUCUS SPECIMEN TRAP
FDA 510(k)
FDA Class 2
·General Hospital
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 |
| K080688 | C-QUR LITE MESH V-PATCH | Apr 16, 2008 | Substantially Equivalent |