IV SHUTTLE
FDA 510(k) clearance K950367 · decided 1995-04-26
Clearance details
- K-number
- K950367
- Device name
- IV SHUTTLE
- Applicant
- Equipment Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-31
- Decision date
- 1995-04-26
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- FOX
- Device class
- 1
- Regulation number
- 880.6990
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Phoenix, AZ, 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 |
|---|---|---|
| IV STANDS (K980336) | Clinton Industries, Inc. | 1998-04-06 |
| MEDRAD CONTRAST HOLDER (K964782) | Medrad, Inc. | 1997-02-25 |
| PORT-A-POLE (K961470) | Prins Medical Ind., Inc. | 1996-07-22 |
| HIGH VOLUME I.V. & IRRIGATION TOWER (K960027) | Allen Medical Systems, Inc. | 1996-03-12 |
| IV POLE/STAND (K952196) | Valentine Intl. , Ltd. | 1995-07-31 |
| STAND, INFUSION (K946201) | Medical Specialties, Inc. | 1995-04-18 |
| FLEXSYS MOBILEMATE EQUIPMENT STAND (K944580) | Hill-Rom, Inc. | 1995-03-17 |
| MOBILE CARE IV STAND (K932498) | Mobile Care, Inc. | 1993-10-27 |
| PNEUMATIC IRRIGATION STANDARD (K925066) | Arthrodyn, Inc. | 1993-07-28 |
| I.V. SKY-HOOK (K912010) | Dina - Industria, Comercio E Exportacao , Ltd. | 1991-08-19 |
| INTRAVENOUS STAND OR IV STAND (K900981) | Travl-Med Infusion Device Transport System | 1990-03-27 |
| AIV SYSTEMS' IV POLES (K895776) | Automated IV Systems, Inc. | 1990-02-28 |
Recalls involving this device
No recalls on record reference this clearance.