Lock-It Plus Regional Anesthesia Catheter Securement Device, Model 100/399/216
FDA 510(k) K051524 · Smiths Medical Asd, Inc.
510(k) numberK051524
Submission
- Device name
- Lock-It Plus Regional Anesthesia Catheter Securement Device, Model 100/399/216
- Applicant
- Smiths Medical Asd, Inc.
Keene, NH, US - Received
- June 8, 2005
- Decision date
- July 7, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSO – Catheter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5120
- Specialty
- Anesthesiology
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Questions and answers
When was Lock-It Plus Regional Anesthesia Catheter Securement Device, Model 100/399/216 cleared by the FDA?
Lock-It Plus Regional Anesthesia Catheter Securement Device, Model 100/399/216 (K051524) received a 510(k) decision of Substantially Equivalent on July 7, 2005, 29 days after the submission was received.
What is the product code of K051524?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.