Chrysalis Intelligence · Product Codes · QJZ

QJZ · Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

Cardiovascular · 4 clearances · 2 unique sponsors

Device class
Class II
Regulation 870.4100
Total clearances
4
2020-02-21 → 2026-07-31
Last 12 months
1
Unique sponsors
2
Definition

What is Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.4100
Implant
N
Life-sustain / support
Y
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Fresenius Medical Care Renal Therapies Group, LLC 2 0 2024-04-15
Medtronic, Inc. 2 1 2026-07-31
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
33948 CPT High ECMO/extracorporeal cardiopulmonary bypass cannulation is standard CPT code
33949 CPT High Extracorporeal membrane oxygenation (ECMO) initiation and daily management
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-31 K261335 Medtronic, Inc. VitalFlow Set with Balance™ Biosurface
2024-09-12 K240880 Medtronic, Inc. VitalFlow Set with Balance Biosurface
2024-04-15 K232926 Fresenius Medical Care Renal Therapies Group, LLC Novalung ultimate kit (US)
2020-02-21 K191407 Fresenius Medical Care Renal Therapies Group, LLC Novalung System