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FDA 510(k)

ACHELASIA BALLOON DIALATOR

K-Number: K884715 · 1989-09-29

ApplicantPrimrose Medical, Inc.
Decision Date1989-09-29
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACHELASIA BALLOON DIALATOR is the device name listed in this FDA 510(k) record. The listed applicant is Primrose Medical, Inc.. It received FDA 510(k) clearance on 1989-09-29 under 510(k) number K884715. The device is classified under product code KNQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACHELASIA BALLOON DIALATOR?

ACHELASIA BALLOON DIALATOR is a medical device that received FDA 510(k) clearance on 1989-09-29. The listed applicant is Primrose Medical, Inc.. The 510(k) number is K884715.

When did ACHELASIA BALLOON DIALATOR receive FDA 510(k) clearance?

ACHELASIA BALLOON DIALATOR received FDA 510(k) clearance on 1989-09-29, under 510(k) number K884715.

Who is the listed applicant for ACHELASIA BALLOON DIALATOR?

The FDA 510(k) record lists Primrose Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACHELASIA BALLOON DIALATOR?

The FDA product code for ACHELASIA BALLOON DIALATOR is KNQ.

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Other records listing Primrose Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K884711URETHRAL AND URETERAL BALLOON DILATATORSK884714BILIARY DIALATORK884713COLONIC BALLOON DIALATORSK884712ESOPHAGEAL AND PYLORIC BALLOON DIALATORSK884709ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)K883420LANCET, BLOOD

View all 14 devices →

Related Devices (Code: KNQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122924CRE FIXED WIRE BALLON DILATION CATHETERBoston Scientific CorpK093236ETHICON ENDO-SURGERYOPTICAL DILATOREthicon Endo-Surgery, Inc.K090183HERCULES 3 STAGE WIRE GUIDED DILATION BALLOONCook EndoscopyK082995SMART DILATORSafestitch MedicalK061937COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOONCook EndoscopyK061787MAXFORCE TTS SINGLE-USE BALLOON DILATORBoston Scientific Corp

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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