510(k) Report

Devices descending from K990284

8 later devices reach Baylis Medical RF Septostomy Generator, Nykanen RF Septostomy Catheter, Baylis… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150709ProTrack RF Anchor WireBaylis Medical Company, Inc.201571
+2K261745LightningWire Transseptal Puncture System (TPS)ElectroWire Medical20260—
+2K242076VersaCross™ RF WireBaylis Medical Company20242—
+2K240900HOTWIRE™ RF GuidewireAtraverse Medical20242—
+3K260839Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc.20260—
+3K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135…Pressure Products Medical Device Manufacturing, LLC20260—
+3K252419Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical, Inc.20251—
+4K260292Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical20260—