Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter System
FDA 510(k) K032390 · Ebi, L.P.
510(k) numberK032390
Submission
- Device name
- Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter System
- Applicant
- Ebi, L.P.
Parsippany, NJ, US - Received
- August 4, 2003
- Decision date
- August 29, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K093057 | Biomet Vision Footring SystemKTT · Traditional | 12/01/2009SE |
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| K091381 | Ibex Spinal SystemMAX · Traditional | 08/07/2009SE |
| K090203 | 5.5 Helical Flange Spinal System, Polaris ComponentsNKB · Special | 07/30/2009SE |
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Questions and answers
When was Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter System cleared by the FDA?
Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter System (K032390) received a 510(k) decision of Substantially Equivalent on August 29, 2003, 25 days after the submission was received.
What is the product code of K032390?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.