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FDA 510(k)

MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM

K-Number: K973113 · 1997-11-10

ApplicantBoston Scientific Corp
Decision Date1997-11-10
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM 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 1997-11-10 under 510(k) number K973113. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM?

MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-10. The listed applicant is Boston Scientific Corp. The 510(k) number is K973113.

When did MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM receive FDA 510(k) clearance?

MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM received FDA 510(k) clearance on 1997-11-10, under 510(k) number K973113.

Who is the listed applicant for MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM?

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 MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM?

The FDA product code for MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM is FGE.

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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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