Company ยท US
Katecho, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2001. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 7 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 4 |
| GXY | Electrode, Cutaneous | 4 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 4 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 |
| DRX | Electrode, Electrocardiograph | 2 |
| ELE | Implant, Subperiosteal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 12, 2001 | K012404 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 Katecho, Inc. | DRO |
| May 23, 2001 | K010543 | KM-30 TENS ELECTRODE Katecho, Inc. | GXY |
| Dec 14, 2000 | K003228 | K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A Katecho, Inc. | MKJ |
| Nov 21, 2000 | K002806 | K-DEFIB/PACE, MODEL KDP-60A Katecho, Inc. | MKJ |
| Nov 7, 2000 | K000870 | KM-10 TENS ELECTRODE Katecho, Inc. | GXY |
| Feb 3, 2000 | K993745 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 Katecho, Inc. | MKJ |
| Aug 23, 1999 | K991007 | K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 Katecho, Inc. | MKJ |
| Dec 9, 1998 | K981737 | K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 Katecho, Inc. | MKJ |
| Nov 17, 1995 | K954504 | K-DEFIB/PACE PEDIATRIC ELECTRODE Katecho, Inc. | MKJ |
| Jan 24, 1995 | K934692 | K-DEFIB/PACE PEDIATRIC ELECTRODE Katecho, Inc. | MKJ |
| Aug 3, 1994 | K940801 | K-KLIP Katecho, Inc. | DRX |
| Jul 25, 1994 | K935083 | PEDIATRIC DEFIB K-PADS Katecho, Inc. | LDD |
| Jun 9, 1994 | K940586 | K-SNAP Katecho, Inc. | DRX |
| May 17, 1993 | K922202 | K-STIM CLEAR Katecho, Inc. | GZJ |
| Apr 15, 1993 | K926175 | K-DEFIB/PACE CARBON ELECTRODE Katecho, Inc. | DRO |
| Oct 6, 1992 | K921679 | K-DISPERSE Katecho, Inc. | GZJ |
| Jun 29, 1992 | K915328 | GEL-TAC Katecho, Inc. | DRO |
| May 14, 1992 | K914955 | K-DEFIB/PACE ELECTRODE Katecho, Inc. | DRO |
| Jan 30, 1992 | K913031 | K-STIM Katecho, Inc. | GXY |
| Jan 30, 1992 | K912381 | LOW BACK STRIP (OR) K-BACK Katecho, Inc. | GZJ |
| Jul 30, 1991 | K912587 | K-FREE Katecho, Inc. | LDD |
| Mar 13, 1990 | K900997 | K-STERILE TENS ELECTRODES Katecho, Inc. | GXY |
| Jan 18, 1990 | K895662 | DEFIB K-PADS Katecho, Inc. | LDD |
| Nov 12, 1986 | K863899 | K-STIK DEFIBRILLATION PADS Katecho, Inc. | LDD |
| Jun 5, 1985 | K843829 | K-MESH Katecho, Inc. | |
| Nov 30, 1984 | K843557 | K-APATITE 20-40 MESH K-APATITE 40-60 Katecho, Inc. | ELE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||