Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
The Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure is a Class 2 cardiovascular device consisting of an extracorporeal circuit and accessories intended to support patients with long-term respiratory or cardiopulmonary failure. It requires 510(k) clearance and is regulated under 21 CFR 870.4100 within the Cardiovascular medical specialty. The product code is QJZ, and the device is flagged as life-sustaining given its role in maintaining respiratory and cardiac function in critically ill patients. It is not an implant.
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Basic Information
- Product Code
- QJZ
- Device Class
- FDA class 2
- Regulation Number
- 870.4100
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240880 | VitalFlow Set with Balance Biosurface | Sep 12, 2024 | Substantially Equivalent | Medtronic, Inc. |
| K232926 | Novalung ultimate kit (US) | Apr 15, 2024 | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC |
| K191407 | Novalung System | Feb 21, 2020 | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.