Nautica Micro Catheter, Model 105-5094-153
FDA 510(k) K024122 · Micro Therapeutics, Inc.
510(k) numberK024122
Submission
- Device name
- Nautica Micro Catheter, Model 105-5094-153
- Applicant
- Micro Therapeutics, Inc.
Irvine, CA, US - Received
- December 16, 2002
- Decision date
- March 7, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRA – Catheter, Continuous Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1210
- Specialty
- Cardiovascular
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| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmKRA · Traditional | Ablative Solutions, Inc. | 07/05/2023SE |
| K231148 | ScleroSafe 150 mm, ScleroSafe 350 mmKRA · Traditional | Vvt Medical , Ltd. | 06/20/2023SE |
| K230957 | TriSalus TriNav® LV Infusion SystemKRA · Traditional | Trisalus Life Sciences | 05/02/2023SE |
| K223139 | Wallaby 017 Micro CatheterKRA · Traditional | Wallaby Medical | 04/25/2023SE |
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Questions and answers
When was Nautica Micro Catheter, Model 105-5094-153 cleared by the FDA?
Nautica Micro Catheter, Model 105-5094-153 (K024122) received a 510(k) decision of Substantially Equivalent on March 7, 2003, 81 days after the submission was received.
What is the product code of K024122?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.