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FDA 510(k)

Perfect-O Ostial Positioning Catheter

K-Number: K260289 · 2026-06-05

ApplicantBalosmark, Inc.
Decision Date2026-06-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Perfect-O Ostial Positioning Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Balosmark, Inc.. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K260289. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Perfect-O Ostial Positioning Catheter?

Perfect-O Ostial Positioning Catheter is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Balosmark, Inc.. The 510(k) number is K260289.

When did Perfect-O Ostial Positioning Catheter receive FDA 510(k) clearance?

Perfect-O Ostial Positioning Catheter received FDA 510(k) clearance on 2026-06-05, under 510(k) number K260289.

Who is the listed applicant for Perfect-O Ostial Positioning Catheter?

The FDA 510(k) record lists Balosmark, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perfect-O Ostial Positioning Catheter?

The FDA product code for Perfect-O Ostial Positioning Catheter is DQY.

Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott MedicalK260993Amplatzer TorqVue Delivery SystemAbbottK253361Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80ABBOTT MEDICALK253409C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)Medtronic, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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