Novasight Hybrid System
FDA 510(k) K172258 · Conavi Medical, Inc.
510(k) numberK172258
Submission
- Device name
- Novasight Hybrid System
- Applicant
- Conavi Medical, Inc.
Toronto, CA - Received
- July 26, 2017
- Decision date
- April 27, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
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|---|---|---|---|
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| K252945 | Novasight Hybrid SystemOBJ · Traditional | Conavi Medical, Inc. | 04/17/2026SE |
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| K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid…OBJ · Special | Abbott Medical | 05/23/2025SE |
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Questions and answers
When was Novasight Hybrid System cleared by the FDA?
Novasight Hybrid System (K172258) received a 510(k) decision of Substantially Equivalent on April 27, 2018, 275 days after the submission was received.
What is the product code of K172258?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.