Rebar Micro Catheter: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker Band and 153 CM, Dual Marker Band
FDA 510(k) K001966 · Micro Therapeutics, Inc.
510(k) numberK001966
Submission
- Device name
- Rebar Micro Catheter: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker Band and 153 CM, Dual Marker Band
- Applicant
- Micro Therapeutics, Inc.
Irvine, CA, US - Received
- June 28, 2000
- Decision date
- July 20, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
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| K230957 | TriSalus TriNav® LV Infusion SystemKRA · Traditional | Trisalus Life Sciences | 05/02/2023SE |
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Questions and answers
When was Rebar Micro Catheter: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker Band and 153 CM, Dual Marker Band cleared by the FDA?
Rebar Micro Catheter: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker Band and 153 CM, Dual Marker Band (K001966) received a 510(k) decision of Substantially Equivalent on July 20, 2000, 22 days after the submission was received.
What is the product code of K001966?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.