MSI PROCEDURE KIT
FDA 510(k) clearance K944226 · decided 1995-06-21
Clearance details
- K-number
- K944226
- Device name
- MSI PROCEDURE KIT
- Applicant
- Msi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-30
- Decision date
- 1995-06-21
- Days to decision
- 295 days
- Clearance type
- Traditional
- Product code
- DOX
- Device class
- 2
- Regulation number
- 862.3550
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Tarpon Springs, FL, 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 |
|---|---|---|
| KAYAK HYDROPHILIC GUIDE WIRES (K014195) | Boston Scientific Corp | 2002-03-19 |
| HYDRO-SIL(TM) COATED GUIDEWIRES (K900822) | National-Standard Medical Products | 1990-07-17 |
| HEPARIN COATED STAINLESS STEEL/TEFLON (K832030) | Argon Medical Corp. | 1983-09-29 |
Recalls involving this device
No recalls on record reference this clearance.