STAT 2 IV PUMPETTE
FDA 510(k) clearance K905498 · decided 1991-04-16
Clearance details
- K-number
- K905498
- Device name
- STAT 2 IV PUMPETTE
- Applicant
- The Master Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-07
- Decision date
- 1991-04-16
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- LDR
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| 3M IV FLOW REGULATOR (K896907) | 3M Company | 1990-02-26 |
| VARI-SET (K894111) | Sonex Medical | 1989-09-28 |
| IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ (K894487) | Y | 1989-09-27 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 F recall (Z-0629-2012) | ConMed Corporation | 2012-01-11 |
| STAT 2 Secondary Set Gravity Flow Controller, 20 Drops/cc, 13 in. length, Catalog/REF No. recall (Z-0634-2012) | ConMed Corporation | 2012-01-11 |
| STAT 2 Pumpette I.V. Compensating Controller, Catalog/REF No. PS2, ASSEMBLED IN MEXICO, CO recall (Z-0682-2012) | ConMed Corporation | 2012-01-11 |
| STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller, 12" length, Catalog/RE recall (Z-0683-2012) | ConMed Corporation | 2012-01-11 |