Heyer Schulte Corp.
United StatesFDA applicant, unverified
- Devices
- 9
What Heyer Schulte Corp. makes
Heyer Schulte Corp. manufactures medical devices for surgical and subcutaneous applications, including two-way Kelman chamber maintainers for tissue expansion, subcutaneous tissue expanders, and flushing valves designed to prevent syphilis transmission. Their portfolio also includes T-tube drains, lumbar nerve root shields, and aseptic transfer sets for sterile fluid handling.
The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with most submissions recorded via the 510(k) pathway. Products are listed in the FDA’s regulatory database, and the manufacturer operates from the United States.
Catalogue
2 Fr Kelman Chamber Maintainer Ref K792096
Regimes: 510(k) Registry: 510(k)Radovan Subcutaneous Tissue Expander Ref K771224
Regimes: 510(k) Registry: 510(k)Mishler 2 Chamb Flushing Valve, Anti-Syph Ref K760785
Regimes: 510(k) Registry: 510(k)Valve, Standard Model Pudenze Flushing Ref K760501
Regimes: 510(k) Registry: 510(k)Mishler 2 Chamb Flushing Valve, Stand Ref K760784
Regimes: 510(k) Registry: 510(k)T-Tube Drain, Round Ref K760778
Regimes: 510(k) Registry: 510(k)Subcutaneous Tissue Expander Ref K790842
Regimes: 510(k) Registry: 510(k)Lumbar Nerve Root Shield Ref K780706
Regimes: 510(k) Registry: 510(k)Aseptic Transfer Set Ref K780417
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Heyer Schulte Corp. have in the registry?
The registry currently lists 9 devices for Heyer Schulte Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heyer Schulte Corp.'s devices?
Among its 9 most recently registered devices, Heyer Schulte Corp. has devices listed in FDA 510(k) (9 devices).
What risk classes do Heyer Schulte Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Heyer Schulte Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Heyer Schulte Corp. in the registry?
The most recently registered devices listed for Heyer Schulte Corp. include 2 FR KELMAN CHAMBER MAINTAINER, RADOVAN SUBCUTANEOUS TISSUE EXPANDER, MISHLER 2 CHAMB FLUSHING VALVE, ANTI-SYPH and VALVE, STANDARD MODEL PUDENZE FLUSHING.