KAYAK HYDROPHILIC GUIDE WIRES
FDA 510(k) clearance K014195 · decided 2002-03-19
Clearance details
- K-number
- K014195
- Device name
- KAYAK HYDROPHILIC GUIDE WIRES
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2001-12-21
- Decision date
- 2002-03-19
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DOX
- Device class
- 2
- Regulation number
- 862.3550
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Maple Grove, 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 |
|---|---|---|
| MSI PROCEDURE KIT (K944226) | Msi, Inc. | 1995-06-21 |
| 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.