PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (K251253)
Description
PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port by Bard Access Systems, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251253
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (K251253) cites 8 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ... | Bard Access Systems, Inc. | 2024 |
| K133335 | POWERPORT IMPLANTABLE PORT | C.R. Bard, Inc. | 2014 |
| K081311 | POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER | C.R. Bard, Inc. | 2008 |
| K073423 | MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER | C.R. Bard, Inc. | 2007 |
| K072549 | TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX ... | C.R. Bard, Inc. | 2007 |
| K072215 | TITANIUM POWERPORT ISP IMPLANTED PORT | C.R. Bard, Inc. | 2007 |
| K063377 | POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER | C.R. Bard, Inc. | 2007 |
| K060812 | POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CAT... | C.R. Bard, Inc. | 2006 |
Trace the full predicate network for K251253
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.