Seeker Crossing Support Catheter
FDA 510(k) K103367 · Bard Peripheral Vascular, Inc.
510(k) numberK103367
Submission
- Device name
- Seeker Crossing Support Catheter
- Applicant
- Bard Peripheral Vascular, Inc.
Tempe, AZ, US - Received
- November 16, 2010
- Decision date
- December 8, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Other 510(k)s with product code DQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260559 | NHanceITDQY · Traditional | IMDS Operation B.V. | 08/14/2026SE |
| K262392 | APRO 35 Swift CatheterDQY · Special | Alembic, LLC | 08/12/2026SE |
| K262240 | SSPC NXT Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261766 | CPS Locator 3D Plus Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY · Special | Abbott | 07/02/2026SE |
| K261631 | Amplatzer TorqVue Exchange SystemDQY · Special | Abbott Medical | 06/17/2026SE |
| K260289 | Perfect-O Ostial Positioning CatheterDQY · Traditional | Balosmark, Inc. | 06/05/2026SE |
| K260993 | Amplatzer TorqVue Delivery SystemDQY · Special | Abbott | 04/24/2026SE |
| K253361 | Teleport Glide MicrocatheterDQY · Traditional | OrbusNeich Medical (Shenzhen) Co., Ltd. | 04/10/2026SE |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/…DQY · Special | Abbott Medical | 03/13/2026SE |
More from Abbott Medical
| 510(k) | Device | Decision |
|---|---|---|
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | 08/14/2026SE |
| K260012 | UltraScore Focused Force PTA BalloonPNO · Special | 02/04/2026SE |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Traditional | 12/12/2025SE |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument KitKNW · Special | 07/10/2025SE |
| K250219 | Dorado PTA Balloon Dilatation CatheterDQY · Traditional | 06/17/2025SE |
| K243642 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | 03/24/2025SE |
| K242757 | Rotarex Atherectomy SystemMCW · Special | 01/30/2025SE |
| K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal…PNG · Traditional | 12/06/2024SE |
| K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG…LJT · Special | 12/08/2023SE |
| K221440 | Liverty TIPS Access SetDYB · Traditional | 05/31/2022SE |
Questions and answers
When was Seeker Crossing Support Catheter cleared by the FDA?
Seeker Crossing Support Catheter (K103367) received a 510(k) decision of Substantially Equivalent on December 8, 2010, 22 days after the submission was received.
What is the product code of K103367?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.