Company ยท US
Luther Medical Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1998. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 6 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 4 |
| DYB | Introducer, Catheter | 2 |
| DQR | Cannula, Catheter | 1 |
| DQX | Wire, Guide, Catheter | 1 |
| GCD | Connector, Catheter | 1 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 1 |
| LKX | Device, Thermal, Hemorrhoids | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 30, 1998 | K982797 | BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB Luther Medical Products, Inc. | DYB |
| Mar 24, 1998 | K980090 | ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) Luther Medical Products, Inc. | LJS |
| Feb 10, 1998 | K974543 | L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER Luther Medical Products, Inc. | FOZ |
| Dec 15, 1994 | K940198 | L-CATH CONNECTOR ASSEMBLY Luther Medical Products, Inc. | GCD |
| Jul 26, 1994 | K942103 | L-CATH CATHETER SYSTEM - PORT L-CATH Luther Medical Products, Inc. | LJT |
| Apr 7, 1994 | K930473 | ONECATH L-CATH CATHETER SYSTEM Luther Medical Products, Inc. | LJS |
| Mar 22, 1994 | K925236 | L CATH(R) CATHETER SYSTEM Luther Medical Products, Inc. | LJS |
| Jun 7, 1993 | K920755 | L-CATH PEEL AWAY SYSTEM CATHETER Luther Medical Products, Inc. | LJS |
| May 27, 1993 | K925979 | DUAL LUMEN L-CATH CATHETER SYSTEM Luther Medical Products, Inc. | DQX |
| May 21, 1993 | K924968 | L-CATH PEEL-AWAY CATHETER SYSTEM Luther Medical Products, Inc. | FOZ |
| Feb 25, 1993 | K924562 | CATHETER INTRODUCER Luther Medical Products, Inc. | DYB |
| Feb 8, 1989 | K884806 | LUMED EXPANDO-CATH, ACTIV Luther Medical Products, Inc. | FOZ |
| Jun 17, 1987 | K871546 | SAFESIDE(TM) LUMED Luther Medical Products, Inc. | FOZ |
| Jan 9, 1986 | K853348 | L-CATH EXPANDO CATH Luther Medical Products, Inc. | FOZ |
| Sep 24, 1982 | K822217 | THERMOTHERAPY Luther Medical Products, Inc. | LKX |
| Jan 29, 1982 | K820102 | SUBCLAVIAN JUGULAR CATHETER SET Luther Medical Products, Inc. | DQR |
| Aug 20, 1980 | K801575 | L-CATH INTRAVENOUS PLACEMENT UNIT Luther Medical Products, Inc. | FOZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||