3M IV FLOW REGULATOR
FDA 510(k) clearance K896907 · decided 1990-02-26
Clearance details
- K-number
- K896907
- Device name
- 3M IV FLOW REGULATOR
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1989-12-08
- Decision date
- 1990-02-26
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- LDR
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| VARI-SET (K894111) | Sonex Medical | 1989-09-28 |
| IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ (K894487) | Y | 1989-09-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |