A.S.A.P.
FDA 510(k) clearance K841318 · decided 1984-07-18
Clearance details
- K-number
- K841318
- Device name
- A.S.A.P.
- Applicant
- Trimedyne, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-02
- Decision date
- 1984-07-18
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- LDR
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DEKA Infusion System, DEKA Administration Set (K242693) | Deka Research and Development Corporation | 2024-10-07 |
| DEKA Infusion System, DEKA Administration Set (K232316) | Deka Research and Development | 2024-03-01 |
| Volumetric Infusion Controller (K153760) | DEKA Research & Development | 2016-10-03 |
| PACER MODEL 100 INFUSION CONTROLLER (K963136) | Health Watch, Inc. | 1997-10-10 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P (K971865) | Alexander Mfg. Co. | 1997-07-03 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 (K971826) | Alexander Mfg. Co. | 1997-07-03 |
| UNIVERSAL CONTROLLER, MODEL 100 (K934543) | Metamed, Inc. | 1994-03-29 |
| FLOW CONTROLLING EXTENSION SET (K935236) | Block Medical, Inc. | 1994-02-24 |
| MASTER FLOW I.V. PUMPETTE (K905497) | The Master Medical Corp. | 1991-04-16 |
| STAT 2 IV PUMPETTE (K905498) | The Master Medical Corp. | 1991-04-16 |
| 3M IV FLOW REGULATOR (K896907) | 3M Company | 1990-02-26 |
| VARI-SET (K894111) | Sonex Medical | 1989-09-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S026) | Trimedyne, Inc. | 1994-03-17 |
| SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S016) | Trimedyne, Inc. | 1994-03-17 |
| TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S027) | Trimedyne, Inc. | 1994-03-01 |
| SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S015) | Trimedyne, Inc. | 1992-03-20 |
| SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S014) | Trimedyne, Inc. | 1992-01-29 |
| MODEL 1210 OMNIPULSE(TM) HOLMIUM LASER SYSTEM (P870043/S013) | Trimedyne, Inc. | 1991-08-20 |
| TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S025) | Trimedyne, Inc. | 1991-02-25 |
| 2.5 HOLIUM/ND:YAG SPECTRAPROBE FLEX CATHETER (P870043/S011) | Trimedyne, Inc. | 1990-11-14 |