FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design
K Number: K171275
·
Decision Dec 20, 2017
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
175
Review Days
233
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design
- K Number
- K171275
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- May 1, 2017
- Decision Date
- December 20, 2017
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYB), ordered by most recent decision date.
FieldFlex Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Echo Large Bore Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Introducer Sheath Set
FDA 510(k)
FDA Class 2
·Cardiovascular
Edwards eSheath+ introducer set
FDA 510(k)
FDA Class 2
·Cardiovascular
Aventus Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Protaryx Transseptal Puncture Device (PTX2-001)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Cook Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K233177 | Nest VT Vitrification Device | Mar 8, 2024 | Substantially Equivalent |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval Set | May 16, 2023 | Substantially Equivalent |
| K223098 | Bakri Essential Postpartum Balloon | Oct 28, 2022 | Substantially Equivalent |
| K210734 | Endovascular Dilator and Sets | Apr 6, 2021 | Substantially Equivalent |
| K203670 | Extra Large Check-Flo Introducer | Feb 16, 2021 | Substantially Equivalent |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc | Jan 29, 2020 | Unknown |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture Set | Dec 16, 2019 | Substantially Equivalent |
| K191163 | Lumax Guiding Catheter | Dec 12, 2019 | Substantially Equivalent |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set | Dec 12, 2019 | Substantially Equivalent |
| K190084 | McLean-Ring Enteral Feeding Tube Set | Oct 11, 2019 | Substantially Equivalent |