Modified Seldinger Initial Puncture Instrument
FDA 510(k) K875327 · Schneider-Shilley (Usa)
510(k) numberK875327
Submission
- Device name
- Modified Seldinger Initial Puncture Instrument
- Applicant
- Schneider-Shilley (Usa)
Minneapolis, MN, US - Received
- December 29, 1987
- Decision date
- March 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Xcardia Innovation , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K882826 | Softrac-Pta Peripheral Dilatation CatheterLIT · Traditional | 01/24/1989SE |
| K875175 | Modified Peripheral Dilatation CathetersLIT · Traditional | 07/28/1988SE |
| K881197 | Softrac-Pta(Tm) Peripheral Dilatation CatheterLIT · Traditional | 05/16/1988SE |
| K875323 | Modified Schneider-Shiley Wire TorquerDQX · Traditional | 03/28/1988SE |
| K875322 | Modified Schneider-Shiley Pressure ManometerKRK · Traditional | 03/28/1988SE |
| K875324 | Modified Schneider Shiley Inflation SyringesDXT · Traditional | 03/25/1988SE |
| K875326 | Modified Schneider-Shiley Flushing CatheterDQO · Traditional | 02/18/1988SE |
| K875325 | Modified Occluder/Flushing Catheter StopcockDQO · Traditional | 02/18/1988SE |
Questions and answers
When was Modified Seldinger Initial Puncture Instrument cleared by the FDA?
Modified Seldinger Initial Puncture Instrument (K875327) received a 510(k) decision of Substantially Equivalent on March 25, 1988, 87 days after the submission was received.
What is the product code of K875327?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.