510(k) K181757
- Device
- Günther Tulip® Vena Cava Filter Retrieval Set
- Applicant
- Cook Incorporated
- 510(k) number
- K181757
- Product code
- MMX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-06
- Date received
- 2018-07-02
- Regulation
- 870.5150
- Classification name
- Device, Percutaneous Retrieval
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Steven Lawrie
- Address
- 750 Daniels Way; P.O. Box 489 Bloomington IN US 47402 47402
FDA Registration Numbers#
- 1721676
- 2017865
- 3013557562
- 3003637635
- 3003524171
- 2183870
- 1018233
- 3011137372
- 1047843
- 3007829657
- 9616662
- 3008988055
- 1625425
- 3013666336
- 3009039068
- 3002807314
- 3009018440
- 3015309643
- 3008423561
- 2020394
- 3023527320
- 1313046
- 3012536737
- 3013288201
- 3004111573
- 3006082230
- 1820334
- 3005941719
- 2134812
- 3033589330
- 3015225571
- 3005704822
- 1721504
- 2183744
- 3023548693
- 3006950086
Source Documents#
Other 510(k) Records For Product Code MMX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242776 | LimFlow V-Ceiver | LimFlow, Inc. | 2025-02-14 |
| K241259 | Amplatz Goose Neck Snare Kit | Medtronic, Inc. | 2024-06-03 |
| K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | Argon Medical Devices, Inc. | 2023-09-07 |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval Set | Cook Incorporated | 2023-05-16 |
| K222083 | LimFlow V-Ceiver | LimFlow, Inc. | 2022-08-09 |
| K212988 | ONO Retrieval Device | Onocor Vascular, LLC | 2022-05-23 |
| K213494 | Aveir Retrieval Catheter | ABBOTT MEDICAL | 2022-04-01 |
| K200963 | Halo Single-Loop Microsnare Kit | Argon Medical Devices, Inc. | 2021-01-05 |
| K200268 | Halo™ Single-Loop Snare Kit | Argon Medical Devices, Inc. | 2020-06-03 |
| K193507 | Merit ONE Snare System | Merit Medical Systems, Inc. | 2020-01-17 |
| K191758 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | Argon Medical Devices, Inc. | 2019-12-17 |
| K170987 | Captus Vascular Retrieval System | Avantec Vascular Corporation | 2017-08-28 |
| K163307 | Expro Elite Snare, Sympro Elite Snare | Vascular Solutions, Inc. | 2017-03-08 |
| K160593 | Indy OTW Vascular Retriever | Cook Incorporated | 2016-09-02 |
| K152136 | Recovery Cone Removal System | C.R. Bard, Inc. | 2016-02-18 |
Legacy Summary#
summary
FDA Review#
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