# K974222: Ces Masstransit Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Feb 10, 1998 after 90 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945904 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952874: Transit Infusion Catheter, Cordis Neurovascular, Inc. (1995) Summary page 2.
- K936260: Transit Infusion Catheter, Cordis Corp. (1994) Summary page 2.
- K936282: Transit Infusion Catheter (Neurovascular Use), Cordis Neurovascular, Inc. (1994) Summary page 2.
- K965181: Ces Infusion Catheter, Cordis Neurovascular, Inc. (1997) Summary page 2.
- K972518: Transit/Rapidtransit/Speedster/Prowler Infusion Catheter, Cordis Neurovascular, Inc. (1997) Summary page 2.
- K960806: Turbo Tracker, Target Therapeutics (1996) Summary page 2.
- (no number) Jetstream 327: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K953900: FasTRACKER 325. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.
- K953892: FasTRACKER 325. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Indications for use
CES MassTRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic and embolic agents into the peripheral, coronary and neurovasculatures.

Source page: https://510kreport.com/device/K974222
Methodology: https://510kreport.com/methodology