Percor Percutaneous Introducer
FDA 510(k) K820834 · Datascope Corp.
510(k) numberK820834
Submission
- Device name
- Percor Percutaneous Introducer
- Applicant
- Datascope Corp.
Mchenry, IL, US - Received
- March 26, 1982
- Decision date
- April 14, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
Other 510(k)s with product code DYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | Medline Industries, LP | 07/29/2026SE |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…DYB · Traditional | Hartman Medical Group, LLC | 07/06/2026SE |
| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolGDW · Traditional | 12/26/2019SE |
| K181122 | CARDIOSAVE Intra-Aortic Balloon PumpDSP · Special | 05/31/2018SE |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDSP · Special | 10/12/2017SE |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…DSP · Special | 01/31/2017SE |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDSP · Special | 07/02/2015SE |
| K133074 | Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDSP · Special | 12/12/2013SE |
| K071805 | Netguard Automated Clinician Alert System, Model 0998-00-1600-XXDSI · Abbreviated | 09/25/2007SE |
| K062569 | Safeguard 24 CM Pressure Assisted DressingDXC · Abbreviated | 02/14/2007SE |
| K062098 | Spectrum Monitor, Model 0998-00-1000-XXXXXMHX · Abbreviated | 02/05/2007SE |
| K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…DSP · Special | 01/05/2007SE |
Questions and answers
When was Percor Percutaneous Introducer cleared by the FDA?
Percor Percutaneous Introducer (K820834) received a 510(k) decision of Substantially Equivalent on April 14, 1982, 19 days after the submission was received.
What is the product code of K820834?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.