Sentinel Cerebral Protection System
FDA 510(k) K192460 · Boston Scientific Corporation
510(k) numberK192460
Submission
- Device name
- Sentinel Cerebral Protection System
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- September 9, 2019
- Decision date
- February 19, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PUM – Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1251
- Specialty
- Cardiovascular
Embolic protection for transcatheter intracardiac procedures
Other 510(k)s with product code PUM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261715 | Emboliner Embolic Protection System (EPC-03)PUM · Traditional | Emboline, Inc. | 09/08/2026SE |
More from Emboline, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262151 | SpaceOAR Flex SystemOVB · Traditional | 09/11/2026SE |
| K262460 | Rezum SystemKNS · Traditional | 09/03/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | 08/26/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | 08/21/2026SE |
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | 08/12/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | 08/04/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | 07/24/2026SE |
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | 07/24/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | 07/10/2026SE |
Questions and answers
When was Sentinel Cerebral Protection System cleared by the FDA?
Sentinel Cerebral Protection System (K192460) received a 510(k) decision of Substantially Equivalent on February 19, 2020, 163 days after the submission was received.
What is the product code of K192460?
The FDA product code is PUM – Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures, a Class II (moderate risk) device regulated under 21 CFR 870.1251.