Atlantis SR, Model C4020; Atlantis SR Plus, Model 35975
FDA 510(k) K040776 · Boston Scientific Corp
510(k) numberK040776
Submission
- Device name
- Atlantis SR, Model C4020; Atlantis SR Plus, Model 35975
- Applicant
- Boston Scientific Corp
Fremont, CA, US - Received
- March 26, 2004
- Decision date
- April 29, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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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| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
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Questions and answers
When was Atlantis SR, Model C4020; Atlantis SR Plus, Model 35975 cleared by the FDA?
Atlantis SR, Model C4020; Atlantis SR Plus, Model 35975 (K040776) received a 510(k) decision of Substantially Equivalent on April 29, 2004, 34 days after the submission was received.
What is the product code of K040776?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.