15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
FDA 510(k) K191871 · Boston Scientific Corporation
510(k) numberK191871
Submission
- Device name
- 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- July 12, 2019
- Decision date
- August 7, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
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Questions and answers
When was 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set cleared by the FDA?
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set (K191871) received a 510(k) decision of Substantially Equivalent on August 7, 2019, 26 days after the submission was received.
What is the product code of K191871?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.