Giant Lumen Safetip Series: Endomyocardial Biopsy
FDA 510(k) K903840 · Intec Medical, Inc.
510(k) numberK903840
Submission
- Device name
- Giant Lumen Safetip Series: Endomyocardial Biopsy
- Applicant
- Intec Medical, Inc.
Danvers, MA, US - Received
- August 21, 1990
- Decision date
- October 16, 1990
- 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 |
|---|---|---|
| K911840 | Interflo Medical Model PA3-H Cco/Pac CatheterDYG · Traditional | 06/03/1991SE |
| K903217 | Tapered Tip the Guider Coronary Guiding CatheterDQY · Traditional | 10/19/1990SE |
| K903216 | The Guider Coronary Guiding CatheterDQY · Traditional | 10/19/1990SE |
| K900710 | Interflo Medical Model F-1 Thermodilution CatheterKRB · Traditional | 10/19/1990SE |
| K903906 | Percutaneous Catheter Introducer KitDYB · Traditional | 09/26/1990SE |
| K900998 | Interventional Medical Y Adapter W/Adjust. ValveDQY · Traditional | 08/14/1990SE |
| K901247 | Tri Adapter W/Adjustable Hemostasis ValvesDYG · Traditional | 07/31/1990SE |
| K894925 | Amcath Ureteral Dilators Models 7100,7110,7120EZN · Traditional | 12/13/1989SE |
| K860941 | Disposable Heated Wire Loops 48 and 72BZE · Traditional | 04/02/1986SE |
| K823271 | Disposable Adult Vo. Ventilator CircuitBZO · Traditional | 12/22/1982SE |
Questions and answers
When was Giant Lumen Safetip Series: Endomyocardial Biopsy cleared by the FDA?
Giant Lumen Safetip Series: Endomyocardial Biopsy (K903840) received a 510(k) decision of Substantially Equivalent on October 16, 1990, 56 days after the submission was received.
What is the product code of K903840?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.