FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPIOX SX10 HARDSHELL RESEVOIR
K Number: K991973
·
Decision Sep 3, 1999
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
168
Applicant Total
143
Review Days
84
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
- CAPIOX SX10 HARDSHELL RESEVOIR
- K Number
- K991973
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Medical Corp.
- Date Received
- June 11, 1999
- Decision Date
- September 3, 1999
- Product Code
- DTN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTN), ordered by most recent decision date.
Inspire HCR and HCR DUAL cardiotomy reservoirs
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Hybrid System
FDA 510(k)
FDA Class 2
·Cardiovascular
MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL
FDA 510(k)
FDA Class 2
·Cardiovascular
BMR 1900 PHISIO
FDA 510(k)
FDA Class 2
·Cardiovascular
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
FDA 510(k)
FDA Class 2
·Cardiovascular
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Terumo Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K111606 | PINNACLE PRECISION ACCESS SYSTEM | Oct 3, 2011 | Substantially Equivalent |
| K111556 | GLIDECROSS SUPPORT CATHETER | Jul 29, 2011 | Substantially Equivalent |
| K110540 | TERUMO SUPPORT CATHETER | May 13, 2011 | Substantially Equivalent |
| K102008 | GLIDESHEATH | Jul 21, 2010 | Substantially Equivalent |
| K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | May 29, 2009 | Substantially Equivalent |
| K082997 | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER | Apr 15, 2009 | Substantially Equivalent |
| K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | Feb 6, 2009 | Substantially Equivalent |
| K082847 | PINNACLE ROII INTRODUCER SHEATH | Oct 29, 2008 | Substantially Equivalent |
| K082519 | FINECROSS MG CORONARY MICRO-GUIDE CATHETER | Sep 26, 2008 | Substantially Equivalent |
| K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER | Sep 24, 2008 | Substantially Equivalent |