CELSIUS CONTROL SYSTEM— 510(k) K033623
Substantially EquivalentInnercool Therapies, Inc.
FDA 510(k) clearance K033623 for CELSIUS CONTROL SYSTEM, Substantially Equivalent on 2004-05-21. Applicant: Innercool Therapies, Inc.. Device class: 2.
Clearance details
- Applicant
- Innercool Therapies, Inc.
- Product code
- Code NCX
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego,, CA, US
Recent devices under product code NCX
view all- K223746 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
- K220008 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
- K213031 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
- K152946 — TEMPEDY
- K153162 — Hypocore
Adverse events under product code NCX
product code NCX- Death
- 30
- Malfunction
- 2,302
- Total
- 2,332
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.