Modification to Transseptal Introducer Set
FDA 510(k) K020090 · Thomas Medical Products, Inc.
510(k) numberK020090
Submission
- Device name
- Modification to Transseptal Introducer Set
- Applicant
- Thomas Medical Products, Inc.
Malvern, PA, US - Received
- January 10, 2002
- Decision date
- February 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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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 |
| K081341 | Reinforced Catheter Introducer System (Rcis)DYB · Traditional | 05/14/2008SE |
| 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 |
| K013202 | Modification to Braided Guiding IntroducerDYB · Special | 10/23/2001SE |
Questions and answers
When was Modification to Transseptal Introducer Set cleared by the FDA?
Modification to Transseptal Introducer Set (K020090) received a 510(k) decision of Substantially Equivalent on February 11, 2002, 32 days after the submission was received.
What is the product code of K020090?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.