Perfect-O Ostial Positioning Catheter
FDA 510(k) K260289 · Balosmark, Inc.
510(k) numberK260289
Submission
- Device name
- Perfect-O Ostial Positioning Catheter
- Applicant
- Balosmark, Inc.
Kalamazoo, MI, US - Received
- January 29, 2026
- Decision date
- June 5, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
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| 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 |
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| K261631 | Amplatzer TorqVue Exchange SystemDQY · Special | Abbott Medical | 06/17/2026SE |
| 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 |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB…DQY · Traditional | Medtronic, Inc. | 12/19/2025SE |
Questions and answers
When was Perfect-O Ostial Positioning Catheter cleared by the FDA?
Perfect-O Ostial Positioning Catheter (K260289) received a 510(k) decision of Substantially Equivalent on June 5, 2026, 127 days after the submission was received.
What is the product code of K260289?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.