Acist Plus 4 Angiographic Catheter
FDA 510(k) K021015 · Acist Medical Systems
510(k) numberK021015
Submission
- Device name
- Acist Plus 4 Angiographic Catheter
- Applicant
- Acist Medical Systems
Eden Prairie, MN, US - Received
- March 29, 2002
- Decision date
- April 26, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
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| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemDXT · Special | 12/17/2020SE |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterOBJ · Special | 03/20/2020SE |
| K190473 | ACIST RXi System and Navvus II CatheterOBI · Traditional | 09/13/2019SE |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000…DXT · Traditional | 07/18/2019SE |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ · Traditional | 06/27/2019SE |
| K171646 | ACISTCVi® Contrast Delivery SystemDXT · Traditional | 02/16/2018SE |
Questions and answers
When was Acist Plus 4 Angiographic Catheter cleared by the FDA?
Acist Plus 4 Angiographic Catheter (K021015) received a 510(k) decision of Substantially Equivalent on April 26, 2002, 28 days after the submission was received.
What is the product code of K021015?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.