Flexible Dilating Sheath
FDA 510(k) K945586 · Med Institute, Inc.
510(k) numberK945586
Submission
- Device name
- Flexible Dilating Sheath
- Applicant
- Med Institute, Inc.
West Lafayette, IN, US - Received
- November 14, 1994
- Decision date
- April 4, 1997
- 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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|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| 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 |
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| 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 |
| 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 |
| K951076 | Vital-Port Petite Dual Vascular Access SystemLJT · Traditional | 06/13/1995SE |
Questions and answers
When was Flexible Dilating Sheath cleared by the FDA?
Flexible Dilating Sheath (K945586) received a 510(k) decision of Substantially Equivalent on April 4, 1997, 872 days after the submission was received.
What is the product code of K945586?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.