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FDA 510(k)

MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER

K-Number: K933020 · 1994-01-03

ApplicantBoston Scientific Corp
Decision Date1994-01-03
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1994-01-03 under 510(k) number K933020. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER?

MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 1994-01-03. The listed applicant is Boston Scientific Corp. The 510(k) number is K933020.

When did MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER receive FDA 510(k) clearance?

MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER received FDA 510(k) clearance on 1994-01-03, under 510(k) number K933020.

Who is the listed applicant for MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER?

The FDA product code for MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER is EYB.

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Related Devices (Code: EYB)

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.

K192183RocaTub Ureteral CatheterPromepal SamK191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc.K183323UPJ Occlusion Balloon CatheterCook IncorporatedK182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook IncorporatedK182122Ureteric CathetersColoplast Corp.K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated

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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