The Boston & Pacific Co., Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What The Boston & Pacific Co., Inc. makes
The Boston & Pacific Co., Inc. manufactures urinary catheters, including external male catheters and indwelling urological catheters, as well as urinary drainage accessories like leg bags and drain bags.
These products are regulated under FDA Class I and Class II categories, with some devices cleared via the 510(k) pathway. The company’s devices are listed in the FDA’s 510(k) registry.
Catalogue
4 Sure External Male Catheter Ref K896726
Regimes: 510(k) Registry: 510(k)4 Sure Urological Catheter Ref K896725
Regimes: 510(k) Registry: 510(k)4 Sure Urinary Leg Bag Ref K896728
Regimes: 510(k) Registry: 510(k)4 Sure Urinary Drain Bag Ref K896727
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does The Boston & Pacific Co., Inc. have in the registry?
The registry currently lists 4 devices for The Boston & Pacific Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list The Boston & Pacific Co., Inc.'s devices?
Among its 4 most recently registered devices, The Boston & Pacific Co., Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do The Boston & Pacific Co., Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for The Boston & Pacific Co., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from The Boston & Pacific Co., Inc. in the registry?
The most recently registered devices listed for The Boston & Pacific Co., Inc. include 4 SURE EXTERNAL MALE CATHETER, 4 SURE UROLOGICAL CATHETER, 4 SURE URINARY LEG BAG and 4 SURE URINARY DRAIN BAG.