Facility

PRYTIME MEDICAL DEVICES, INC.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012279212
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	575 Union Blvd Suite 107 Lakewood, CO, US 80228
Registration status	Active · expires 2026
Parent company	Prytime Medical Devices, Inc. (owner-operator 10050783)
Brand names	pREBOA-PRO Catheter

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Catheter, Intravascular Occluding, Temporary
Product code MJN (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4450

Recalls & enforcement

Class IITerminated2020-12-14
There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular access then the guidewire included in the kit will not pass through the access needle to facilitate insertion of an intr…
Class IITerminated2020-10-29
There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient.

FDA inspections (1)

NAI2018-07-17
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “PRYTIME MEDICAL DEVICES, INC. (FEI 3012279212) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012279212-prytime-medical-devices-inc/

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