Ivt Introducer Sheath
FDA 510(k) K903463 · Intensive Technology, Inc.
510(k) numberK903463
Submission
- Device name
- Ivt Introducer Sheath
- Applicant
- Intensive Technology, Inc.
San Diego, CA, US - Received
- August 1, 1990
- Decision date
- January 3, 1991
- 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 |
|---|---|---|
| K922970 | Intra-Operative Tec Atherectomy SystemMCW · Traditional | 01/13/1993SE |
| K912664 | Tec Rotating Dual HemovalveDYB · Traditional | 08/24/1992SE |
| K911869 | Ivt Guiding CatheterDQY · Traditional | 10/16/1991SE |
| K904003 | Hemochron(R) Heparin Response TestKFF · Traditional | 11/29/1990SE |
| K901767 | Modified Ivt Peripheral AtherectomyLIT · Traditional | 06/28/1990SE |
| K896403 | Modified Ivt Peripheral Atherectomy SystemLIT · Traditional | 03/06/1990SE |
| K895903 | Ivt 0.014 Guide WireDQX · Traditional | 01/04/1990SE |
| K892209 | Aptt by Hemochron(R)GFO · Traditional | 06/22/1989SE |
| K890515 | Peripheral Atherectomy SystemDWX · Traditional | 05/23/1989SE |
| K882804 | 0.014 Peripheral Guide WireDQX · Traditional | 10/28/1988SE |
Questions and answers
When was Ivt Introducer Sheath cleared by the FDA?
Ivt Introducer Sheath (K903463) received a 510(k) decision of Substantially Equivalent on January 3, 1991, 155 days after the submission was received.
What is the product code of K903463?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.