Workstation Femoral Intravascular Retrieval (Modi)
FDA 510(k) K914555 · Med Institute, Inc.
510(k) numberK914555
Submission
- Device name
- Workstation Femoral Intravascular Retrieval (Modi)
- Applicant
- Med Institute, Inc.
West Lafayette, IN, US - Received
- October 7, 1991
- Decision date
- January 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
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| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
More from Xcardia Innovation , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K990034 | Wilson-Cook Colonic Z-StentMQR · Traditional | 04/17/2000SE |
| K982507 | Mini Polyurethane CatheterLJT · Traditional | 09/16/1998SE |
| K981061 | Intravascular Retrieval DeviceGCC · Traditional | 05/26/1998SE |
| K964001 | Swartz Doppler Flow Probe and Monitor SystemITX · Traditional | 04/17/1998SE |
| K971140 | Vital-Port Infusion PalLJT · Traditional | 11/17/1997SE |
| K970442 | Target Vital-Port Vascular Access SystemLJT · Traditional | 04/30/1997SE |
| K945586 | Flexible Dilating SheathDRE · Traditional | 04/04/1997SE |
| K960698 | Non-Coring NeedleFMI · Traditional | 04/15/1996SE |
| K941228 | Endoluminal Access TubeKNT · Traditional | 09/27/1995SESK |
| K951077 | Vital-Port Petiet Polysulfone Vascular Access SystemLJT · Traditional | 07/31/1995SE |
Questions and answers
When was Workstation Femoral Intravascular Retrieval (Modi) cleared by the FDA?
Workstation Femoral Intravascular Retrieval (Modi) (K914555) received a 510(k) decision of Substantially Equivalent on January 3, 1992, 88 days after the submission was received.
What is the product code of K914555?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.