STYLETTE, SLICK, CAT. NO. 2000B— 510(k) K770374
Substantially EquivalentMedical Products Div. P.O.L.A. Plasti
FDA 510(k) clearance K770374 for STYLETTE, SLICK, CAT. NO. 2000B, Substantially Equivalent on 1977-03-30. Applicant: Medical Products Div. P.O.L.A. Plasti. Device class: 1.
Clearance details
- Applicant
- Medical Products Div. P.O.L.A. Plasti
- Product code
- Code BSR
- Device class
- Class 1
- Regulation
- 21 CFR 868.5790
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code BSR
view all- K162729 — Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
- K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
- K954771 — TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
- K943104 — MOLLOY INTUBATING STYLETTE
- K955238 — RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
Adverse events under product code BSR
product code BSR- Death
- 2
- Other
- 1
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.