Aries Medical, Inc.
Walker, MI, US
Aries Medical, Inc. appears in FDA device records in Walker, MI. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Aries Medical, Inc. between 1984 and 1991. The busiest year on record is 1987, with 7. The most recent is 1991, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 5 |
| 1985 | 2 |
| 1987 | 7 |
| 1988 | 1 |
| 1990 | 3 |
| 1991 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K912604 | SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF | KFM | Substantially Equivalent | |
| K903925 | ARIES MELDICAL MODEL 2100HC HANK CRANK | KFM | Substantially Equivalent | |
| K903442 | ARIES TAPERSEAL(TM) SHEATH | DYB | Substantially Equivalent | |
| K895433 | ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS | DSP | Substantially Equivalent | |
| K882289 | ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. | DSY | Substantially Equivalent | |
| K864994 | 40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER | DSP | Substantially Equivalent | |
| K864537 | 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER | DSP | Substantially Equivalent | |
| K864568 | 40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER | DSP | Substantially Equivalent | |
| K864567 | 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER | DSP | Substantially Equivalent | |
| K871140 | ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER | DYB | Substantially Equivalent | |
| K870189 | ARIES TAPERED SHEATH | DYB | Substantially Equivalent | |
| K863185 | 40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON | DSP | Substantially Equivalent | |
| K844220 | ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO | DSP | Substantially Equivalent | |
| K850111 | AIRES TUOHY NEEDLES 17GA. X 4 1/2 | BSP | Substantially Equivalent | |
| K842004 | PERCUTANEOUS CATHETER INTRODUCER SET | DYB | Substantially Equivalent | |
| K833632 | ARIES MEDICAL MODEL 700 | DSP | Substantially Equivalent | |
| K840201 | EPIDURAL CATHETER TRAY | MJL | Substantially Equivalent | |
| K840202 | EPIDURAL CATHETER | BSO | Substantially Equivalent | |
| K840641 | VESSEL DILATOR | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain