Ministik Mini Puncture Set Catalog Code #57505
FDA 510(k) K871137 · Dlp, Inc.
510(k) numberK871137
Submission
- Device name
- Ministik Mini Puncture Set Catalog Code #57505
- Applicant
- Dlp, Inc.
Grand Rapids, MI, US - Received
- March 20, 1987
- Decision date
- July 16, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
Other 510(k)s with product code DQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035DQX · Traditional | Filmecc Co., Ltd. | 09/03/2026SE |
| K253667 | Accoat Guide WireDQX · Traditional | Sp Medical A/S | 07/14/2026SE |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
| K254137 | InQwire Amplatz Guide WireDQX · Traditional | Merit Medical Ireland, Ltd. | 05/22/2026SE |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…DQX · Special | FMD Co., Ltd. | 03/20/2026SE |
| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special | Merit Medical Ireland, Ltd. | 01/31/2026SE |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
| K252674 | Solo Pace Fusion System (SOLOFUSE1)DQX · Traditional | Solo Pace, Inc. | 01/09/2026SE |
More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973485 | Clearview Blower/MisterFQH · Traditional | 12/08/1997SE |
| K964445 | Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)DWS · Traditional | 01/30/1997SE |
| K953945 | Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff & Introducer…DWF · Traditional | 03/26/1996SE |
| K950754 | Macro Suction Tube Model No 10061GCY · Traditional | 04/25/1995SE |
| K934215 | Contain-OrKKX · Traditional | 02/09/1994SE |
| K915268 | Catheter Two Stage Venous ReturnDWF · Traditional | 07/27/1992SE |
| K914608 | Breast Les Local Wire St. 48219/49220/48119/48120GAA · Traditional | 01/09/1992SE |
| K913077 | Lancaster Cooling Jacket, Cat. Code #13500/13501DTR · Traditional | 01/09/1992SE |
| K913098 | Apiration Biopsy Syringe Gun, Cat. Code #54501KNW · Traditional | 11/05/1991SE |
| K912229 | Ima Electrocautery Electrode Cat. #60002/60003GEI · Traditional | 09/25/1991SE |
Questions and answers
When was Ministik Mini Puncture Set Catalog Code #57505 cleared by the FDA?
Ministik Mini Puncture Set Catalog Code #57505 (K871137) received a 510(k) decision of Substantially Equivalent on July 16, 1987, 118 days after the submission was received.
What is the product code of K871137?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.