FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
K Number: K912604
·
Decision Oct 28, 1991
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
83
Applicant Total
19
Review Days
150
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
- SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
- K Number
- K912604
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aries Medical, Inc.
- Date Received
- May 31, 1991
- Decision Date
- October 28, 1991
- Product Code
- KFM
- 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 |
|---|---|---|---|
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KFM), ordered by most recent decision date.
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
FDA 510(k)
FDA Class 2
·Cardiovascular
LifeSPARC System
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
FDA 510(k)
FDA Class 2
·Cardiovascular
Capiox iCP Centrifugal Pump
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Aries Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903925 | ARIES MELDICAL MODEL 2100HC HANK CRANK | Dec 21, 1990 | Substantially Equivalent |
| K903442 | ARIES TAPERSEAL(TM) SHEATH | Aug 23, 1990 | Substantially Equivalent |
| K895433 | ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS | Apr 10, 1990 | Substantially Equivalent |
| K882289 | ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. | Dec 12, 1988 | Substantially Equivalent |
| K864994 | 40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER | Jun 19, 1987 | Substantially Equivalent |
| K864537 | 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER | Jun 19, 1987 | Substantially Equivalent |
| K864568 | 40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER | May 12, 1987 | Substantially Equivalent |
| K864567 | 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER | May 12, 1987 | Substantially Equivalent |
| K871140 | ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER | Apr 22, 1987 | Substantially Equivalent |
| K870189 | ARIES TAPERED SHEATH | Mar 16, 1987 | Substantially Equivalent |