Reinforced Catheter Introducer System (Rcis)
FDA 510(k) K081341 · Thomas Medical Products, Inc.
510(k) numberK081341
Submission
- Device name
- Reinforced Catheter Introducer System (Rcis)
- Applicant
- Thomas Medical Products, Inc.
Malvern, PA, US - Received
- May 13, 2008
- Decision date
- May 14, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| 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 |
|---|---|---|
| K122431 | Heartspan Steerable Introducer KitDYB · Traditional | 01/29/2013SE |
| K120158 | Coronary Sinus Guide and Lateral Vein Introducer KitsDYB · Traditional | 08/14/2012SE |
| K101015 | Guide Catheters and AccessoriesDQY · Traditional | 09/23/2010SE |
| K083269 | CrossoverDYB · Traditional | 02/03/2009SE |
| K072745 | Y-GlideDTL · Special | 01/04/2008SE |
| K043438 | Large Bore Splittable Introducer KitDYB · Special | 02/15/2005SE |
| K040713 | Modification to Braided Guiding Introducer SystemDYB · Special | 06/01/2004SE |
| K011727 | Transseptal Needle/TrocarDRC · Traditional | 05/02/2002SE |
| K020090 | Modification to Transseptal Introducer SetDYB · Special | 02/11/2002SE |
| K013202 | Modification to Braided Guiding IntroducerDYB · Special | 10/23/2001SE |
Questions and answers
When was Reinforced Catheter Introducer System (Rcis) cleared by the FDA?
Reinforced Catheter Introducer System (Rcis) (K081341) received a 510(k) decision of Substantially Equivalent on May 14, 2008, 1 days after the submission was received.
What is the product code of K081341?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.