Company ยท US
Cardiotronics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1995. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 24, 1995 | K932903 | EKG VEST Cardiotronics, Inc. | DRX |
| Dec 1, 1992 | K922064 | MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE Cardiotronics, Inc. | GXD |
| Sep 18, 1992 | K923297 | MODEL #340 STEALTH-TRODE+LS Cardiotronics, Inc. | LDD |
| Jun 11, 1992 | K922227 | MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE Cardiotronics, Inc. | LDD |
| Jun 11, 1992 | K922173 | MODEL # 830 ST ADULT STIMULATION PADS (STERILE) Cardiotronics, Inc. | LDD |
| Jun 11, 1992 | K922172 | MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) Cardiotronics, Inc. | LDD |
| May 26, 1992 | K921606 | MODEL #125 CHILD STIMULATION PADS Cardiotronics, Inc. | LDD |
| Feb 3, 1992 | K920086 | SHOCK-PATCH ADULT DEFIBRILLATION PADS Cardiotronics, Inc. | LDD |
| Nov 5, 1991 | K914725 | COORDINATOR, CABLE INPUT Cardiotronics, Inc. | DPS |
| Oct 16, 1991 | K912621 | MODEL #911 STEALTH MULTI PADS Cardiotronics, Inc. | LDD |
| Oct 16, 1991 | K911456 | MODEL #110 STEALTH-TRODE CHILD DEFIB PADS Cardiotronics, Inc. | LDD |
| Oct 16, 1991 | K911455 | MODEL #100 SHOCK-TRODE CHILD DEFIB PADS Cardiotronics, Inc. | LDD |
| Oct 3, 1991 | K911402 | MODEL #350 SHOCK-PLATE DEFIB ADAPTOR Cardiotronics, Inc. | LDD |
| Sep 4, 1991 | K913226 | MODEL #810 STEALTH-STIM ADULT STIMULATION PADS Cardiotronics, Inc. | DRX |
| May 2, 1991 | K910661 | MODEL 205 SHOCK-TRODE Cardiotronics, Inc. | DRO |
| Jan 30, 1991 | K904466 | MODEL #250 DEFIB CABLE Cardiotronics, Inc. | LDD |
| Dec 3, 1990 | K904462 | MODEL #210 STEALTH DEFIB PADS Cardiotronics, Inc. | LDD |
| Oct 26, 1989 | K895113 | COORDINATOR Cardiotronics, Inc. | LDD |
| Nov 18, 1988 | K884532 | TRIAD-EP II, PUSHBUTTON, CABLE INPUT Cardiotronics, Inc. | DRO |
| Nov 17, 1988 | K884530 | TRIAD-EP II, PLATE INPUT Cardiotronics, Inc. | DRO |
| Nov 9, 1988 | K883304 | TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY Cardiotronics, Inc. | DRO |
| Nov 9, 1988 | K883178 | TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE Cardiotronics, Inc. | DRO |
| Oct 6, 1988 | K883523 | TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE Cardiotronics, Inc. | DRO |
| Aug 30, 1988 | K883375 | MODEL #918 MULTI-PADS Cardiotronics, Inc. | DRO |
| Aug 30, 1988 | K882338 | MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE Cardiotronics, Inc. | DRO |
| Aug 2, 1988 | K882337 | MODEL #825 ADULT STIM. PADS POLYMER TYPE Cardiotronics, Inc. | LDD |
| Jul 18, 1988 | K880936 | TRIAD-EP Cardiotronics, Inc. | DRO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||