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FDA 510(k)

VESSEL DILATOR AND INTRODUCER SHEATH

K-Number: K882238 · 1988-08-25

ApplicantIdeal Medical, Inc.
Decision Date1988-08-25
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VESSEL DILATOR AND INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Ideal Medical, Inc.. It received FDA 510(k) clearance on 1988-08-25 under 510(k) number K882238. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VESSEL DILATOR AND INTRODUCER SHEATH?

VESSEL DILATOR AND INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 1988-08-25. The listed applicant is Ideal Medical, Inc.. The 510(k) number is K882238.

When did VESSEL DILATOR AND INTRODUCER SHEATH receive FDA 510(k) clearance?

VESSEL DILATOR AND INTRODUCER SHEATH received FDA 510(k) clearance on 1988-08-25, under 510(k) number K882238.

Who is the listed applicant for VESSEL DILATOR AND INTRODUCER SHEATH?

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

What is the FDA product code for VESSEL DILATOR AND INTRODUCER SHEATH?

The FDA product code for VESSEL DILATOR AND INTRODUCER SHEATH is DRE.

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Other records listing Ideal 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.

K944067PEANUT WAND, MODIFICATIONK931115HATCHER STONE-EMBOLIS EXTRACTORK926335IDEAS PEANUT WANDK922161GRICE SOFT TISSUE BIOPSY KITK921922GRICE LAPAROSCOPIC SUTURING NEEDLEK915175REDDICK RETRACTOR

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Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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