Baxter Hemostasis Valve Introducers
FDA 510(k) K981909 · Baxter Edwards
510(k) numberK981909
Submission
- Device name
- Baxter Hemostasis Valve Introducers
- Applicant
- Baxter Edwards
Irvine, CA, US - Received
- June 1, 1998
- Decision date
- November 24, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| 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 |
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| K980487 | Carpenter-Edwards Classic Ring with Duraflo Treatment Models 4425 (Mitral) and 4525…KRH · Traditional | 07/07/1998SE |
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| K964021 | Intramed Side Branch Occlusion (Sbo) System (700095 and 700099)HCG · Traditional | 03/27/1997SE |
| K955839 | Multi-Med Multi-Lumen Central Venous CatheterFOZ · Traditional | 03/25/1996SE |
| K952638 | 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to AS the…LYK · Traditional | 07/28/1995SE |
| K944214 | Baxter Handle Model 1150DTJ · Traditional | 02/10/1995SE |
| K944858 | Baxter Eptfe Externally Supported Vascular GraftsDSY · Traditional | 01/05/1995ST |
| K940795 | Swan-Ganz CC0/SVO2 Thermodilution CatheterDYG · Traditional | 05/24/1994SE |
| K926433 | 4.5F Imagecath(R) Coronary Angioscope, COV45LYK · Traditional | 03/23/1993SE |
Questions and answers
When was Baxter Hemostasis Valve Introducers cleared by the FDA?
Baxter Hemostasis Valve Introducers (K981909) received a 510(k) decision of Substantially Equivalent on November 24, 1998, 176 days after the submission was received.
What is the product code of K981909?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.