Cardiotronics, Inc.
West Carlsbad, CA, US
Cardiotronics, Inc. appears in FDA device records in West Carlsbad, CA. FDA records list 27 510(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
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Cardiotronics, Inc. between 1988 and 1995. The busiest year on record is 1988, with 9. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 9 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 8 |
| 1992 | 7 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K932903 | EKG VEST | DRX | Substantially Equivalent | |
| K922064 | MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE | GXD | Substantially Equivalent | |
| K923297 | MODEL #340 STEALTH-TRODE+LS | LDD | Substantially Equivalent | |
| K922227 | MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE | LDD | Substantially Equivalent | |
| K922173 | MODEL # 830 ST ADULT STIMULATION PADS (STERILE) | LDD | Substantially Equivalent | |
| K922172 | MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) | LDD | Substantially Equivalent | |
| K921606 | MODEL #125 CHILD STIMULATION PADS | LDD | Substantially Equivalent | |
| K920086 | SHOCK-PATCH ADULT DEFIBRILLATION PADS | LDD | Substantially Equivalent | |
| K914725 | COORDINATOR, CABLE INPUT | DPS | Substantially Equivalent | |
| K912621 | MODEL #911 STEALTH MULTI PADS | LDD | Substantially Equivalent | |
| K911456 | MODEL #110 STEALTH-TRODE CHILD DEFIB PADS | LDD | Substantially Equivalent | |
| K911455 | MODEL #100 SHOCK-TRODE CHILD DEFIB PADS | LDD | Substantially Equivalent | |
| K911402 | MODEL #350 SHOCK-PLATE DEFIB ADAPTOR | LDD | Substantially Equivalent | |
| K913226 | MODEL #810 STEALTH-STIM ADULT STIMULATION PADS | DRX | Substantially Equivalent | |
| K910661 | MODEL 205 SHOCK-TRODE | DRO | Substantially Equivalent | |
| K904466 | MODEL #250 DEFIB CABLE | LDD | Substantially Equivalent | |
| K904462 | MODEL #210 STEALTH DEFIB PADS | LDD | Substantially Equivalent | |
| K895113 | COORDINATOR | LDD | Substantially Equivalent | |
| K884532 | TRIAD-EP II, PUSHBUTTON, CABLE INPUT | DRO | Substantially Equivalent | |
| K884530 | TRIAD-EP II, PLATE INPUT | DRO | Substantially Equivalent | |
| K883304 | TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY | DRO | Substantially Equivalent | |
| K883178 | TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE | DRO | Substantially Equivalent | |
| K883523 | TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE | DRO | Substantially Equivalent | |
| K883375 | MODEL #918 MULTI-PADS | DRO | Substantially Equivalent | |
| K882338 | MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE | DRO | Substantially Equivalent | |
| K882337 | MODEL #825 ADULT STIM. PADS POLYMER TYPE | LDD | Substantially Equivalent | |
| K880936 | TRIAD-EP | DRO | Substantially Equivalent |
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
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain