INFUSABLE
FDA 510(k) clearance K911216 · decided 1991-07-22
Clearance details
- K-number
- K911216
- Device name
- INFUSABLE
- Applicant
- Biomedical Dynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-19
- Decision date
- 1991-07-22
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- KZD
- Device class
- 1
- Regulation number
- 880.5420
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Burnsville, MN, 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 |
|---|---|---|
| INFUSION DYNAMICS POWER INFUSER (K974074) | Infusion Dynamics, Inc. | 1998-02-17 |
| MSI PRESSURE INFUSOR (K973843) | Smith Assoc. | 1997-10-29 |
| OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP (K953290) | Olympus America, Inc. | 1995-10-07 |
| PRESSURIZER (K951988) | Promedic, Inc. | 1995-06-14 |
| PRESSURE INFUSION CUFF (K942933) | Circulatory Technology, Inc. | 1994-08-25 |
| KAWASUMI LABORATORIES K-CUFF (K930012) | Kawasumi Laboratories Co., Ltd. | 1993-12-14 |
| ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 (K921168) | Allen Medical Systems, Inc. | 1993-04-21 |
| PRESSURE INFUSER (K913751) | Biomedical Dynamics, Inc. | 1992-01-09 |
| TECNADYNE SURGI-SQUEEZE INFUSION PUMP (K910926) | Tecnadyne Scientific, Inc. | 1991-08-02 |
| BAXTER SINGLE PATIENT USE PRESSURE INFUSOR (K904484) | Tecnadyne Scientific, Inc. | 1990-10-26 |
| LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR) (K901225) | Abbott Laboratories | 1990-08-23 |
| SURGI SQUEEZ (K894927) | Ethox Corp. | 1989-09-11 |
Recalls involving this device
No recalls on record reference this clearance.