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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K261792

510(k) cleared

DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent

Medtronic · Oct 23, 2026 · K261792

FDA cleared the DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent from Medtronic on Oct 23, 2026 under K261792, a traditional 510(k). The review panel was Unknown.

FDA logged the submission as received on May 29, 2026. The decision came 147 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic has 8 other decisions in the tracker over the last 12 months: K262913 (Protégé EverFlex Self-expanding Peripheral Stent System), K262735 (LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)), K262005 (Affera Integrated Mapping System), K261335 (VitalFlow Set with Balance Biosurface).

Questions & Answers

What did FDA clear under K261792?

K261792 is the FDA 510(k) for DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent, submitted by Medtronic. FDA's decision date was Oct 23, 2026.

Who makes the DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent?

Medtronic, based in Mounds View, MN, is the applicant of record for K261792.

How long did the K261792 review take?

FDA received the submission on May 29, 2026 and issued its decision on Oct 23, 2026, 147 days later.

← All decisions in October 2026