SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT
FDA 510(k) clearance K042445 · decided 2004-10-19
Clearance details
- K-number
- K042445
- Device name
- SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT
- Applicant
- Bard Access Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-09
- Decision date
- 2004-10-19
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake City, UT, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.